Careers at I3 Infotek

Role:Junior Project Manager Location – Plano, TX

JD:

1. Should have 2 to 4 years of experience managing NPD / sustenance / EUMDR / regulatory submission projects in medical devices.
2. Should have experience working in medical domain.
3. Experience in project planning, budget planning, resource tracking, project risk tracking, project metrics tracking, and status reporting.
4. Experience in interacting with cross functional teams is a must.
5. Good written and verbal communication is a must.

Job Title – Manufacturing Engineer Location: – Plano, TX/ Sylmar, CA / Pleasanton ,CA Project Type: long term contract No. of position:-2

Job Description :-

• Should possess 02- 03 years of Change management experience
• Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians.
• Perform projects which include new production equipment installation and qualification, process improvements, yield improvements, and cost reductions while supporting daily production activities.
• Collect and analyze in process data to evaluate capability and determine areas for process improvement.
• Drive process improvements and validations through manufacturing implementation and update PFMEAs and master validation plan as required. Author process validation protocols and reports. Including but not limited to equipment IQ, process OQ, process PQ, and product PPQ.
• Provide direct technical support on production issues (e.g. part & assembled product quality dispositions, interim containment actions, root cause analysis, resolution planning, validation, & implementation) under NCMR or CAPA. Provide guidance to other engineers and technicians.
• Coordinate the design, procurement, build and debug of tooling, machinery and test equipment
• Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts like Value Stream mapping, 5S and Visual Workplace.
• Work with cross-functional teams to transfer new products efficiently and effectively into manufacturing.
• Work with various internal and external organizations to optimize manufacturing processes or resolving technical issues w/ on-going products or new products.
• Provide technical support to manufacturing and QA to improve productivity and reduce costs.
• Participate as a manufacturing lead and/or support a lead on cross-functional core teams.
• Performs other related duties and responsibilities, on occasion, as assigned.

Individual should:

• Be innovative, resourceful, and work with minimal direction
• Have excellent organization, problem solving, communication, and team leadership skills
• Work effectively with cross-functional teams

 Preferred

• Medical device experience strongly preferred, International manufacturing experience preferred. Knowledge of ISO and/or FDA quality system regulations as it pertains to design transfer and process control preferred.
• 4 + years’ experience in Manufacturing involving handling multiple projects, strategically prioritize activities across functional teams within Operations/Manufacturing
• BS or MS in Mechanical Engineering preferred

• The R&D Engineer with experience in catheters or equivalent higher-class devices.
• R&D related Labeling Experience & good understanding of ISO 15223-1 process
• Prepare product design verification testing (DVT) protocols and report against design requirement and risk assessment using external standards.
• Prepare technical product documentation including design history files, drawings, bills of materials, Design Verification protocols and reports, engineering change orders (ECO), etc.
• Expertise in Label Artwork updation & Stock Label Update
• Verification & Validation of Product Labeling & Packaging Labeling
• Self-sustained capability to solve design-related challenges and timely support to cross-functional teams as a subject matter expert.
• Design and develop test methods to support additional studies post-commercialization. Plan and execute on product development deliverables.
• Leverage engineering knowledge in conducting complaint evaluations and CAPA investigations to understand potential device and systemic failures.
• Hands on Solidworks Experience 2D / 2D.
• EU-MDR – documentation and process experience

1. Design Verification and validations
2. Sustenance Activities
3. EU MDR Standards
4. Drawing Redlines
5. ISO 15223-1 – Labeling

EU-MDR – documentation and process experience

Validation Engineer will be responsible for a myriad of tasks involved in starting equipment and utilities including protocol generation, and execution of Validation protocols including Vial filling, lyophilization, and sterilization application.

• Perform validation activities on utilities and manufacturing process equipment and instruments.
• Prepare/Update Validation Master Plans, Project Plans, and Protocols; CQV Plans
• Performs testing, collects samples, analyze test results, and prepare validation and Qualification summary reports.
• Prepare system turnover packages in accordance with project procedures by assembling and reviewing all system test documentation (all disciplines) for adequacy and completeness.
• Create and execute commissioning and qualification protocols/test plans for facilities, utilities and equipment using a risk-based approach.
• Author, review and execute validation protocols, reports, product impact assessments for vial filling, lyophilization and support utilities.

• BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology. • 5- 10 years of experience in validation within the pharmaceutical/biotechnology industry or MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology.
• Experience in aseptic fill/finish unit operations (Vial washing, freeze/thaw, mixing, sterile filtration, filling, stoppering, lyophilization, etc.) to define critical process parameters
• Aseptic fill finish manufacturing or manufacturing technical services experience
• Understanding of process related stresses that impact the quality and stability of biologics
• Fill/finish process validation and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools.

Please forward me  resume with rate and contact#.

Organization Overview:

The Root Cause Investigator will serve as a primary investigator for site investigations into Quality and HSE events to ensure timely and accurate completion of thorough investigations and identification of root cause and corrective/preventive action needed to prevent recurrence. The Root Cause Investigator also serves as a mentor to the functional area Lead Investigators. As such, the Root Cause Investigator plays a key role in the site’s continuous improvement efforts in order to ensure the safe and continuous supply of high quality medicine.

Responsibilities:

1. Lead investigations to adequately identify rootcause and implement appropriate corrective and preventative actions to prevent recurrence by:

• Lead problem solving and rootcauseanalysis sessions
• Interact with multiple functions including, but not limited to, QA, QC, Engineering, TS/MS, Operations, HSE
• Manage highly complex and visible investigations using different rootcausemethodologies such as Pareto, 5 Why’s, Causal Factor Charting, Human Error Checklist, Fishbone, and Fault Tree.
• Ensure effective implementation of corrective and preventive actions
• Assess effectiveness of corrective/preventive actions implemented

1. Utilize technical writing strategies to ensure content is clear, concise, and complete.
2. Monitor and ensure the health of the site’s Deviation Management System by participating in metrics reviews, Management Reviews, etc.
3. Train, coach and mentor functional area Lead Investigators in aspects of incident/observation reporting, problem solving, and risk management associated with root cause investigations, investigation write-ups, development of CAPA and associated effectiveness checks.
4. Observe activities on the manufacturing floor and laboratory; engage with Process Owners to gain the process knowledge needed to deliver technically sound investigations and action plans.
5. Maintain current awareness of regulations, industry trends, and regulatory agency interpretation of GMP Deviation Management System requirements.
6. Maintain and build investigation skills through ongoing training and education. Participate in inspection readiness activities and support regulatory inspections by discussing investigations as required with regulatory agencies.

Basic Requirements:

• Bachelor’s degree or higher in the sciences, engineering, or related field. Candidates with no degree and 10+ years of experience in various functions supporting GMP will also be considered.
• Strong knowledge of GMP and quality systems with a minimum of 3 years of experience in manufacturing and laboratory operations.

Experience within the Biopharmaceutical industry is preferred.

• Excellent technical writing skills required.
• Requires strong skills related to coaching and mentoring others.
• Strong problem solving and analytical skills are required.
• Experience with a variety of root cause
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
• Possess knowledge of core manufacturing principles and support systems.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision.
• Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), TrackWise (preferred).

Additional Skills/Preferences:

• Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.
• Demonstrated Business Acumen.
• Speak up with ideas, concerns & to ensure safety of others.
• Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings.
• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
• Demonstrated success in influencing without authority.
• Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
• Highly flexible, adapting to changes in priorities, requirements and processes.

Organization Overview:

The Root Cause Investigator will serve as a primary investigator for site investigations into Quality and HSE events to ensure timely and accurate completion of thorough investigations and identification of root cause and corrective/preventive action needed to prevent recurrence. The Root Cause Investigator also serves as a mentor to the functional area Lead Investigators. As such, the Root Cause Investigator plays a key role in the site’s continuous improvement efforts in order to ensure the safe and continuous supply of high quality medicine.

Responsibilities:

1. Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent recurrence by:

• Lead problem solving and root cause analysis sessions
• Interact with multiple functions including, but not limited to, QA, QC, Engineering, TS/MS, Operations, HSE
• Manage highly complex and visible investigations using different root cause methodologies such as Pareto, 5 Why’s, Causal Factor Charting, Human Error Checklist, Fishbone, and Fault Tree.
• Ensure effective implementation of corrective and preventive actions
• Assess effectiveness of corrective/preventive actions implemented

1. Utilize technical writing strategies to ensure content is clear, concise, and complete.
2. Monitor and ensure the health of the site’s Deviation Management System by participating in metrics reviews, Management Reviews, etc.
3. Train, coach and mentor functional area Lead Investigators in aspects of incident/observation reporting, problem solving, and risk management associated with root cause investigations, investigation write-ups, development of CAPA and associated effectiveness checks.
4. Observe activities on the manufacturing floor and laboratory; engage with Process Owners to gain the process knowledge needed to deliver technically sound investigations and action plans.
5. Maintain current awareness of regulations, industry trends, and regulatory agency interpretation of GMP Deviation Management System requirements.
6. Maintain and build investigation skills through ongoing training and education. Participate in inspection readiness activities and support regulatory inspections by discussing investigations as required with regulatory agencies.

Basic Requirements:

• Bachelor’s degree or higher in the sciences, engineering, or related field. Candidates with no degree and 10+ years of experience in various functions supporting GMP will also be considered.
• Strong knowledge of GMP and quality systems with a minimum of 3 years of experience in manufacturing and laboratory operations.

• Excellent technical writing skills required.
• Requires strong skills related to coaching and mentoring others.
• Strong problem solving and analytical skills are required.
• Experience with a variety of root cause methodologies.
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
• Possess knowledge of core manufacturing principles and support systems.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision.
• Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), TrackWise (preferred).

Additional Skills/Preferences:

• Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.
• Demonstrated Business Acumen.
• Speak up with ideas, concerns & to ensure safety of others.
• Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings.
• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
• Demonstrated success in influencing without authority.
• Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
• Highly flexible, adapting to changes in priorities, requirements and processes.

Please share your Resume and contact details to this email id: kalyan@i3infotek.com

Job Description:

• Assists the Regulatory Affairs Manager for ensuring compliance with the requirements set by the EU Medical
• Device Regulation and other regulatory bodies for Medical devices registration across different geographies
• Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
• Prepare and review the documentation required for Change submission, Notification, Re-registration of Medical devices
• Provide guidance to the offshore team in the preparation of documents for change submission, notification, re-registration packages of Medical Devices for regulatory agencies submission.
• Understands existing technical files / design dossiers/Technical documentation summary by reviewing documentation available for compliance to CE mark of EU and prepare the Country specific STEDs.
• Performs a Regulatory watch to identify and respond to new or revised regulatory requirements as per the Input by Geo Ras
• Tracks the status of applications under regulatory review and provides updates to the Core Regulatory team.
• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
• Collects, organizes and maintains files on local, regional and global regulatory intelligence and other related information.
• Researches requirements (local, national, international) and options for regulatory submissions, approval pathways and compliance activities.
• Maintains information systems (electronic and paper) for regulatory information and reports.
• Oversee and ensure maintenance of regulatory licenses renewals on timely manner
• Clearly conveys information to peers, supervisors and other stakeholders
• Supports the development of internal RA systems and procedures.
• Maintains SOPs related to RA activity and suggests update of the QMS
• Review of deliverables as Regulatory expert ( STED and Country specific documentation)

Must to have:

• Product Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
• Health Canada, TGA, HAS, CFDA/NMPA, TFDA, PMDA, Anvisa ANMAT, MFDS, MOHW, SFDA, MOH
• Regulatory Submissions / Global Regulatory Submissions/ International Submission
• Medical Device Registration/ Re-registration/ Regulatory licenses renewals
• Change submission, notifications
• STED Preparation
• Regulatory Approbation
• EU MDD/MDR Tech documentation Summary
• Notified Body
• CE Technical File / EU Technical File / Design Dossier

Adds Value:

• RAC Certification: Medical Devices
• FDA 510(K), PMA Submission
• Collateral/Product specific IEC Standards Knowledge
• Support EU MDR Transition activities
• EU MDR Gap Analysis

Required Skillset(s)

• Regulatory knowledge (European Medical device directive and Medical device Regulation)
• Familiarity with standard related to Quality Management Systems (ISO 13485, 21CFR Part 820)
• Regulatory experience in Medical Device Registration Support- APAC, LATAM, EMEA, Canada, China, Russia, Japan
• Project Management experience
• Experience in Regulatory assessment of Engineering/ Design change execution
• Very good written and oral communication in English.
• Ease for reading/creating/modifying documents.

Able to work with minimal supervision. Self-motivated team player.

Please share your Resume and contact details to kalyan@i3infotek.com

This role will support large scope projects, multiple projects, and/or projects of significant strategic importance to the business. Responsible for the design, development, and qualification of electromechanical instruments.

• Supports the DHF remediation project. Identifies all tasks required to complete project assignments according to Design Control procedures. Prepares work plans outlining estimated manpower requirements and development costs.
• Designs for reliability, regulatory compliance, manufacturability, inspectability and optimum cost
• Participates in root cause analysis for problem solving
• Contributes to generation of a comprehensive protocol for testing/analyzing the product
• Prepares definitive new product specifications or modifies existing specifications
• Generates or updates design control documentation for products. Completes factors/Usability documentation for new or existing designs.
• Generates and/or manages the creation of prototype models to evaluate new design concepts
• Possibility of assisting with the validation and writing of software applications for the products
• Responsible for collecting and assessing existing design documents, and to perform a gap analysis of the DHF/Design documentation based on current regulatory agencies' guidelines regarding design control.
• Responsible for organizing an electronic repository and presenting it to appropriate Subject Matter Experts in order to assume a proper knowledge transfer.
• Assist with collection of existing design control documentation and establish an electronic repository for the organization of this documentation in compliance with applicable regulations governing the medical device industry, including but not limited to FDA regulations.
• Review design control activities for existing products including planning, risk assessment, design development, design verification and validation, design review, design change and documentation for design history file.
• Act as liaison with other departments to support design control review activities.
• Review (for accuracy and completeness) verification and validation data, including reports, spreadsheets, statistical summaries, for incorporation into project documentation.
• Perform a full assessment of on-market DHF/design documents to determine gaps and establish protocols to remediate identified gaps.

• Mechanical Engineering degree
• Minimum 3-5 years of experience in Design and Development related position either in development or R&D department in an FDA regulated Industry.
• Full working knowledge of and moderate level of experience with new product development in medical devices, particularly electromechanical device

• Familiarity with various electromechanical standards and testing, including IEC 60601

• Basic Project Management Skills
• Demonstrated ability to methodically investigate, determine appropriate solution and resolve significantly complex problems using current technology
• Ability to process engineering changes and make recommendations based upon business principles
• Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors.
• Demonstrated good written and verbal communication skills including presentation skills
• Working knowledge of drafting standards and geometric dimensioning and tolerancing
• Experience with DHF Remediation Projects
• Must be familiar with current Design Control guidelines.
• Team player (displays enthusiasm, confidence & commitment).
• Microsoft Office Suite and Project
• Ability to take initiatives and work independently.

• Software as a Medical Device Experience (SaMD)
• Experience validating and writing software

The Supplier Quality Consultant will come from a Medical Device background and should have extensive experience in Supplier Quality and Process validation. The client is currently looking to add on another source of manufacturing for over 200 parts that contribute to their existing product line. They need a strong suppler quality engineer to help write and review qualifications on plastic molds and aluminum parts, amongst other things. They will be working with supplier processes, IQ/OQ/PQs, Control Plans, FMEAs etc..

The consultant will also be working with suppliers in Australia. The goal of the 2^nd project is to transfer injector parts to the US. They will be working both internally with the DQE team as well as with suppliers to make sure the transfer goes smoothly. Overall, this is an Individual Contributor type role.

Medical Device: 4 + Years Component Qualification Process Validation IQ/OQ/PQ PPAP Strong Customer-Facing Communication

 Our client is a large medical device manufacturer that develops a number of Medical Device products. They are currently in need of an experienced Design Quality Engineer to support various product development initiatives.

This individual will come from a Medical Device Quality background, with a strong background working on product development efforts. This individual will be responsible for supporting engineering activities leading to the introduction of new product and must have strong expertise within various phases of the design control process including risk management, design V&V, design testing, sterilization validation, biocompatibility studies, statistical analysis, etc. This person will be responsible for reviewing Design History Files (DHF) and FMEAs and other product development documentation to ensure compliance and support the client in identifying what needs to be done to achieve compliance if need be.

This individual must have a strong understanding and the ability to drive design control deliverables, FMEA development, design verification testing, statistical analysis, engineering change orders, etc.

• Medical Device
• Design Quality Engineering
• Risk Management
• Design Controls
• Design Assurance/Design V&V
• Tech File/Design Dossier/DHF
• Understanding of EU MDR

Stent Experience

GENERAL FUNCTION

Reporting to the BD manager, this associate shall plan, lead, review and front-end Design Verification, Sustaining Engineering and New Product Development projects as a technical contributor cum project leader and engages in all aspects of product development / sustenance / remediation.

Bachelor’s or higher education in Mechanical Engineering or related engineering/technology streams (Manufacturing / Mechatronics / Polymer Science / BioMedical)

At least 5-7 years of working experience in design and development of new products, preferably in a regulated industry (Medical Devices / Aerospace).

• MUST have excellent communication skills (verbal, written, presentation & articulation), appropriate for varying levels of stakeholders.
• Strong project management background in R&D or manufacturing environment
• Strong experience in tolerance analysis of plastic components in molding and assembly.
• Excellent analytical and problem-solving skills, as well as a good background in product development/manufacturing process specifically in high volume molding & assembly operations.
• Experience in leading and managing a small group of engineers and technicians
• Demonstrated ability to effectively, critical thinking and clearly communicate concepts, ideas, and knowledge to other individuals and teams.
• Experience in fixture design & development and test method development, implementation and validation.
• Desirable experience with ISO requirements and GMP guidelines, FDA regulations, medical device design control, and manufacturing scale up processes.
• Good on statistical concepts such as in measurement system analysis and design verification.
• Proficient in Microsoft Office products with an emphasis on MS projects, Excel and Word.

1. Leads the Design Verification, Sustaining Engineering & New Product Development projects and applies the best engineering practices and tools.
2. Demonstrates excellent project management, contributes on projects as the R&D member, carrying out assigned responsibilities in a timely, diligent, safe and professional manner.
3. Develops and maintains good rapport with business leaders, other internal functions, technical consultants, outside vendors, and other stakeholders to accomplish project objectives and be a strong team-player.
4. Reviews the deliverables to ensure completeness, accuracy, and appropriateness of the design output/test executed and ensure its compliance with Good Documentation Practices.
5. Provides training to the team on GDP/GLP, IQ/OQ process, Calibration & Preventive maintenance activities and ensures the quality of deliverables.
6. Involves in the review/creation of DV Protocols and provides valuable inputs regarding test equipment selection, capability/accuracy, sample size optimization, acceptance criteria definition, etc.
7. Conducts Weekly Status Review Meeting with stakeholders, shares the progress of various projects supported/led, keeps a track on the self-utilization.
8. Promptly follow-up with the parties concerned for review/approval/signatures of project artifacts (including Memos, MSA, DV Protocol & Reports, IQ/OQ Protocols & Reports, etc).
9. Quality System accountability: Maintains all relevant Protocols, Procedures, Reports and Records to ensure strict compliance of R&D functional operation to meet the Quality System requirements.
10. Supports the organization’s intellectual property strategy by documenting data and independent, unique and patentable ideas that result from experimentations.
11. Performs any other tasks (like Sustaining Engineering / New Product Development activities), as assigned.

• DMR review and remediation for equipment’s
• Documentation review and address any gaps.
• BOM study
• Edit 3D models / drawings, if required
• Review supplier queries and work with customer SMEs
• Change order (CO) drafting & initiate workflow.
• Preferred Electro-mechanical with knowledge in refractive surgical products.
• Experience with solid works is desirable.
• Familiarity of product development life cycle is essential.
• Execute Plant Transfer activities (Transfer of Manufacturing Location and Process validation)
• Metals & Plastic component Qualification including fixtures.
• Experience in Cost Reduction implementation activities (Direct Material Costs)
• Medical device industry in Manufacturing (Process & Product)
• Own up Projects to take it from initiation to finish.
• Fast learner to grasp the development process at customer location.
• Coordinate with suppliers and cross functional teams to ensure project execution.

• Reverse engineering of electro-mechanical fixtures
• Review existing fixture and identify the functional requirements.
• Review existing documentation for fixture.
• Identify sub-systems / components of fixture.
• Prepare structured Bill of materials.
• Create necessary documentation to define design intent of fixture.
• Create / update 3D models / 2D drawings, as required.
• Preferred Electro-mechanical engineers.
• Metals & Plastic component Qualification including fixtures.
• Experience in Cost Reduction implementation activities (Direct Material Costs)
• Medical device industry in Manufacturing (Process & Product)
• Own up Projects to take it from initiation to finish.
• Fast learner to grasp the development process at customer location.
• Coordinate with suppliers and cross functional teams to ensure project execution.

Job Title: Combination R&D Engineer

Job Description:

Update 5/25-Focus should be on Design Verification and exp with 21 CFR 820 Design Controls, exp with R&D New Product Development and Drug Delivery. Looking for a team lead that has demonstrated success in leading large scale projects/products. Phase III Clinical Trials.

They need to have 8+ years of exp and he likes to see candidates from Amgen, Lily and Nordus. Will be leading a team of 8-10 people. They need leadership exp.

******Homerun if candidate has a combination of Drug and Med Device exp.*******

Experience in Structured Product Development using Design Controls in a Medical Device/Combination Product Development industry.

Experience in working with technical requirements, Design Verification testing, protocols and reports writing. Senior Device Engineer will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices (such as Pre Filled Syringes, Auto Injectors, Patch Pumps etc.) for parenteral pharmaceutical therapeutics at Client.

The candidate has technical expertise in the development and commercialization of drug device combination medical products, and provides technical leadership to support engineering, scientific and manufacturing activities within Client s device development programs, including manual injection systems, automated injection systems, and high speed assembly processes.

The Senior Device Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members. The work is reviewed with a focus on long-term perspectives, as the Senior Engineer establishes his/her own work priorities and timelines

Please share your Resume and contact details to this email id: kalyan@i3infotek.com

Job Description

The successful candidate will have a command of CAD/CAM processes that translate customer product models into company standards and creates fixtures, CNC programs and inspection programs for the manufacturing operation. State-of-the-art technologies and processes will be developed and implemented on a foundation of lean manufacturing principles and in compliance with 21 CFR Part 820 and ISO 13485:2016 quality management systems. Candidate thrives in a startup environment where collaboration is vital, resourcefulness is essential, and expanding personal expertise is embraced.

Essential Duties and Responsibilities

• Translate customer models and engineering specs to company standards.
• Generate optimized CNC programs that require minimal set-up for 5-axis mills, CMMs, and other manufacturing equipment.
• Design fixtures and transfer systems that eliminate product set-up cycles on equipment.
• Develop structured and highly automated techniques to minimize the engineering work required to support high-mix, low-volume manufacturing.
• Collaborate with cross-functional team on a cutter and insert selection for tool life and cycle times optimization.
• Develop programming posts for company equipment and effectively utilize simulation software to optimize programs prior to live to debug.
• Meticulously document processes, procedures, and work instructions. Effectively train users on those process elements.
• Improve established processes utilizing lean and or six sigma problem solving techniques.
• Other duties as assigned.

Education and Experience

• Minimum of BS degree in Engineering, Technology, or equivalent experience is required: Mechanical, Manufacturing, Industrial, or related technical field.
• 5 or more years of success-dominated experience that includes CNC programming of 5 axis mills, solid model and print creation and fixture design. (Experience level will dictate the amount of autonomy the employee has.)
• Lean, and or six sigma certifications are preferred.

Knowledge, Skills, & Abilities

• Expert in CNC programming, CAD/CAM systems, workpiece holding.
• Expert on Siemens NXCAD and CAM platforms, simulation packages such as Vericut, and post-processor development.
• Working knowledge of 21 CFR Part 820, Part 11 and ISO 13485.
• Mastered geometric dimensioning and tolerancing, as well as general blueprint reading.
• Proficient with Microsoft Office applications and contemporary DNC systems. Familiarity with ERP systems, eQMS and PLMs desired.
• Effectively communicates using verbal and written media. Accurately and completely captures information and reflects in company records.
• Resourcefully and frugally adapts to workload requirements.

Environmental & Physical Demands

• Work is conducted in an office and manufacturing environment.
• Work hours will periodically fluctuate to support a factory that operates 24 hours per day and 7 days per week.
• Remote work will be accommodated as practical.
• May require long periods of time in front of a computer.

Will be exposed to factory chemicals that include machining lubricants, cleaning detergents, and biological upgrade solutions, as well as metallic powders and dust.

1. Process Engineer

Exciting opportunity with growing global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Process Engineer III will be responsible for facilitating the tech transfer of client processes and executing engineering functions including design and document controls. This individual will also be expected to contribute toward continuous improvement initiatives in support of overall operational efficiencies and improved compliance.

We are open to backgrounds in process engineering or formulation development.

Responsibilities

• Develop batch records for client-specific formulation and filling / finish operations
• Perform processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer
• Operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) as well as finalize closure reports for departures which are assigned to Process Engineering
• Direct verbal and written client interaction, summarizing engineering-related work completed
• Identify and specify process specific equipment needed for client tech transfer, developing techniques and process parameters specific to the client's product while maintaining critical product attributes
• Author instructions for the operation of equipment and for detailing process flows in clean room facility
• Develop new manufacturing and aseptic filling processes to meet client requirements

Requirements

• Bachelors of Science degree in Scientific, Engineering, or related field required
• 5+ years' experience in a cGMP/FDA regulated environment
• Advanced degree in related field may be considered in lieu of experience

Preferred

• Aseptic technique, familiarity with clean room personnel/equipment flows is desirable
• Knowledge of process flows e.g. Disposables strategies, filtration, mixing strategies, fluid transfer to and from various vessels/biobags
• Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design
• Experience with particle size reduction techniques, such as extrusion, microfluidization, or homogenization
• Experience with lyophilization principles
• Familiarity and understanding of cGMP's in a accordance with 21CFR210, and 21CFR211
• Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems)
• Experienced in practicing Quality Risk Management per ICH Q9

1. Burlington, MA  6 months + 2 Openings On-site  preferred.  ( 2 -3 days onsite is also acceptable) Sr. Validation Engineer

   Exciting opportunity with a growing global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

   The Sr. Validation Engineer is responsible for developing and executing validation and revalidation protocols for processes, equipment, utility, and test systems. This person will work with Engineering and Facilities personnel to assure proper installation and operation of systems prior to and post validation. This individual will provide technical support to users of validated systems as required. Will provide assistance to Senior Engineers in support of on-going projects, as well as perform Preventive Maintenance and Calibration tasks as required. The Sr. Validation Engineer works under the direction of the Director or a designate; interacts with all other departments for Engineering and Validation-related issues as required.

   Responsibilities

   • Develop and execute required protocols and complete reports for equipment, process utility, test, and software validations and revalidations as assigned
   • Develop and write Standard Operating Procedures, protocols, incidents, and final reports for new processes and equipment, in conjunction with the system owners
   • Support department projects by assisting senior engineers on ongoing projects
   • Perform Preventive Maintenance and Calibration tasks as required following existing procedures
   • Support internal and external audits by providing data appropriate to the investigation as required
   • Keep Department Management and personnel aware of Engineering related issues that may have a regulatory compliance or financial impact

   Requirements

   • Bachelor's Degree required; Chemical Engineering Degree preferred
   • 3+ years of experience in validation in Pharmaceutical industry
   • Familiarity with validation tools and processes, including temperature mapping and use of Kaye Validator
   • Familiarity with FDA and EU regulations for pharmaceuticals and medical devices
   • Strong technical writing skills are required to author validation documentation
   • Ability to work semi-independently; demonstrated ability to interact well with other technical departments
   • Excellent communication skills

   Physical Demands

   The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

   While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

Exciting opportunity with a growing global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Quality Assurance Specialist III is responsible for maintaining Quality databases and providing on-the-floor QA presence and oversight to the manufacturing operation. The QA Specialist's role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMP's and internal procedures/policies is maintained, b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.

Responsibilities

• Responsible for working cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on Quality Assurance (QA) activities such as the following: On-the-floor support and oversight of manufacturing operations, Executed/Unexecuted Batch Record Review, Executed/Unexecuted Validation/Facility Protocols/Reports, Reviewing Change Controls, Reviewing Facility Work Orders prior to filing
• The QA Specialist III works in coordination with the QA Management to ensure client timelines are on schedule and attainable
• Assist in responsibility for the clients compilation of documentation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
• In conjunction with QA management, coordinate day to day activities on an as needed basis and provide support to QA specialists
• Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP's and clients quality system to ensure real-time compliance
• Represent clients Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented
• Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications
• Monitor Operations personnel for adherence to SOP's. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement
• Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.) and batch records
• Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation
• Authors or revises SOPs
• Performs manufacturing area and labeling clearances as well as inspection of material
• Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports
• Assists in performing investigations
• Performs internal audits and weekly walkthroughs
• External audits for Supplier qualification
• May respond or manage responses to clients regarding manufacturing and/or documentation issues
• Assists in developing and delivering training
• Assists tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
• Develops and/or maintains Quality System metrics for Management Review
• Provides on the floor support to manufacturing operations
• Perform QA visual inspection activities associated with clinical and commercial drug product
• Participate in regulatory and client audits

Requirements

• Bachelor's Degree in the Life Science field; alternate fields of study may be considered in combination with significant Aseptic experience
• 6+ years' experience of pharmaceutical/biotechnology or medical device industry experience; Minimum of 5 years' experience in Quality Assurance
• Excellent written and verbal presentation and communication skills
• Strong problem solving skills, with the ability to resolve conflict
• Ability to effectively present information to management and/or peers

Comfortable working independently in combination with individuals in other departments across the organization

On-site  preferred.  ( 2 -3 days onsite is also acceptable)

Exciting Opportunity at a global contract research and manufacturing services to the pharmaceutical and biotechnology industries.

The Remediation Engineer - Project Manager will execute quality, manufacturing, engineering, and validation compliance remediation activities under direction of technical leadership. Activities may include development, coordination and execution of remediation projects, change requests, protocols and document revisions as required to meet regulatory and cGMP requirements.

Responsibilities

Apply technical knowledge of Operations, Quality, Validation, etc. along with planning and project management skills to execute along and/or trackcoordinate multi-disciplinary teams

• Support project objectives through document reviews, training course development, and hands on training
• Coordinate and communicate progress on scheduled projects
• Manages own time to meet defined objectives

Qualifications

BS in Engineering, Scientific or Technical related field

• 2-4 years' experience in pharmaceutical or similar regulated industry required; prior Engineering, Operations, Quality or Validation assignments preferred
• Experience authoring, review, etc. for procedures or training materials a plus
• Experience and/or training in managing projects is a plus
• Remains organized & positive in ambiguous and fast-paced, rapidly changing situations
• Ability to analyze data from detailed schedule and risk management tools
• Interface effectively with multiple stakeholder groups

1. No OPT and CPT.
2. Onsite role 2. One year contract with possible extension

   Essential Duties and Responsibilities:

   1. Independently plan, execute and direct cross functional engineering projects, that may cross traditional product lines. Diverse new approaches to problems encountered through adaptations and modifications of standard engineering principles. 2. Manage projects on a cross functional basis, including direct supervision of team members. 3. Manage the project costs (all financial aspects) of product development. This will include capital expenditures and cross functional expenses. 4. Identifying and resolve complex problems, including the development of new design experiments, without supervision. 5. Applies state of the art techniques in the area of design controls in evaluation of existing products and processes. 6. Leads the Pharmacy Tools Design History File Remediation program from an Engineering perspective. 7. Performs financial planning and assists in the analysis to justify project approval. 8. Independently plans, schedules and leads cross-functional team in detailed phases of the engineering work in a project.

   Qualification:

   • Good communication skills with matrix management experience required.
   • Independent judgment in the evaluation, selection and adaptation of various engineering techniques required.
   • Must have experience or advanced training and demonstrate proficiency(e.g. computer-aided design, total quality management, design controls, statistical methods, problem analysis and resolution, materials science, design of experiments, software development, change control management).
   • Completely proficient in relevant product development process and/or Design History File remediation.
   • Successful track record of managing wide-ranging activities within the business unit; demonstrating leadership skills.
   • Recognized as a technical expert by peers and other personnel within the business unit.
   • Extensive cross-functional team experience, including technical and non-technical work.
   • Ability to organize and present technical and project mgt. overviews without assistance.
   • Demonstrated success in delivering results on several technical challenges.

   Education/Experience

   • B.S. degree in Engineering and 8-10 years of experience.
   • 2 - 5 years of matrix management experience.
   • Thorough, up to date knowledge of multiple disciplines required.

   Work Environment: Office and Lab work

No OPT and CPT.

Description:

1. Onsite role 2. One year contract with possible extension

   Description:

   This section focuses on the main purpose of the job in one to four sentences. - Applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products or processes. - Plans, executes and functionally directs important engineering assignments, which require independent judgment. This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned. 1) Applies state of the art techniques in the area of expertise to develop new or improved products and processes. 2) May lead a large scale program or several small projects with complex features. 3) Independently plans, schedules and leads cross-functional team in detailed phases of the engineering work in a project. 4) Will supervise one or more engineers and/or technicians. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 1. Must have experience or advanced training and demonstrate proficiency in Computer Aided Design and other key areas, such as: total quality management, statistical methods, problem analysis and resolution, materials science, design of experiments) 2. Completely proficient in Pharmacy Tool products and product development processes including Design History File remediation. 3. Successful track record of managing wide-ranging activities within the business unit, demonstrating leadership skills. 4. Recognized as a technical expert by peers and other personnel within the business unit. 5. Extensive cross-functional team experience, including technical and non-technical work. 6. Ability to organize and present technical and project mgt. overviews without assistance. B.S. degree in Engineering and 8-10 years of experience Demonstrated success in delivering results on several technical challenges

Please share your Resume and Contact details to kalyan@i3infotek.com

• Understanding of the concept of a product Technical Dossier or a Design dossier
• Experience with Regulatory and/or Quality documentation control and change control processes
• Awareness of existence of regulatory requirements, regulatory approvals and importance of regulatory compliance
• Awareness of GMP concepts
• Experience with regulatory audits is a plus but not mandatory
• Able to operate Adaptive system swiftly (conduct searches, extract information, create and manage COs, gathering approvals, creating ad hoc attachments, be able to follow the procedures)
• Knowledge on how to search and extract information from MDRiM system
• Knowledge on how to manage products and licenses in MDRiM system is desired but not mandatory
• SAP and/or JDE skills are a plus, but not mandatory
• Experience with Johnson & Johnson is preferable

Demonstrated expertise with System Design, Risk Analysis, Traceability for embedded control devices

Generally, 2-4 years of experience (no minimum).

Looking for an Engineering Project manager. contact hr@i3infotek.com for more details.

• Bachelor's degree or equivalent experience in related field required
• A minimum of 7+ years related work experience required
• Bachelor's degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering or related field required. Advanced degree in related field or business preferred.
• A minimum of 13+ years related work experience required in device and/or drug development and project management within the device/pharmaceutical industry, or reasonable combination of the two.
• Must have a strong familiarity with the integration of requirements and deliverables associated with Design Controls (21CFR820.30) into the new product development process.
• Must have experience with short release cycles.
• Demonstrated success in large Project/Program Management role including Development and Deployment, preferably healthcare, or closely related is a plus.
• Experience leading large global programs.

Experience managing ambiguity and providing clarity for teams