Careers at I3 Infotek

Please share your contact details and updated resume to kalyan@i3infotek.com Shop Floor QA The Quality Assurance Shop Floor provides QA oversight during manufacturing activities such as filling, compounding, component preparation, capping, inspection, labeling, and packaging operations. QA Shop Floor will also contribute to the training of new employees on QA Shop Floor Associate’s functions. Primary Responsibilities. • Provide shop floor QA oversight for Sterile Manufacturing activities. • Ability to make quality decisions on the floor during commercial manufacturing. • Communicate quality-related observations to management and production personnel and initiate deviations as needed. • Review batch record documentation and logbooks concurrent with manufacturing operations. • Verify line clearance activities for manufacturing and packaging area. • Evaluate manufacturing issues and review Special Attention Notices. • Assist monitoring the inspection and packaging lines by performing AQL inspections and line challenge verification as needed. • Monitor the production schedule and ensure adequate line coverage support from QA. • Perform routine quality inspection of filling, compounding, component preparation, capping, inspection, labeling, packaging, and warehouse. • Support validation and manufacturing studies including special sampling and testing. • Participate in developing and revision of batch record and SOPs. • Providing immediate assistance and support for the sterile manufacturing activities. • Perform retain inspection as a certified inspector.

Job Title	MDR Manufacturing Engineer
Work Country	USA
*Exact Location Candidate will be working at: Please provide full address if possible.	North Haven, Connecticut
Job Type	Contract/ Full time
*How long is this position for? Will this be a  :	12 months; Contract
*Experience Level Required.	Minimum of 2 year of experience
*Job Description	• The Manufacturing Engineer must be familiar with IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) documentation and execution. Conduct, coordinate and aid in formal Process Validations including protocol development and execution. • Working knowledge of manual and automated/semi-automated equipment. The thrust of this assignment is related to pre-printed materials and labeling. • Collaborate on the project team and work under the direction of the Project Manager in a fast-paced environment supporting program initiatives and compliant with company best practices. • Familiar with Agile (Bill of Material & Drawing system) and BPCS (Materials management system). • Generate and revise Bills Of Materials as applied to Versioning. • Working under the guidance of the Senior and/or Principal Engineer. • Excellent organization, Planning, Computer skills, Technical writing, Communication skills.  MS Office Suite and Outlook. • 2 years minimum experience
*Specific Search Key Words to find the right profile -.	Process Validation Engineer IQ, PQ, OQ Medical devices MDD, MDI Labeling
*Education	BE, B tech under graduation in Mechanical, Industrial Engineering

   

Title: Mfg/ Quality engineer

Location: Irvine CA

Description:

Responsibilities may include the following and other duties may be assigned. • Execute remediation validation/ verification activities such as: Operations Qualification (OQ), Process Qualification (PQ)/Process Performance Qualification (PPQ), Design of Experiments (DOEs), Test Method Validations (TMVs), Process Characterization • Provides technical and sustaining engineering support in a manufacturing area. • Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products. • Integrates equipment and material capabilities to meet process module target specifications and technology target specifications. • Interacts with product design and development personnel to ensure that processes and designs are compatible. • May develop and conduct statistical analysis or recommend additions to document work. • This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements. • Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems. • Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. • May have practical knowledge of project management. • Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Title: Manufacturing Engineer

Location: Augusta, GA

Length: 12 months

Details: Manufacturing Engineering is responsible for developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality. ESSENTIAL DUTIES AND RESPONSIBILITIES Create documentation to support new and improved manufacturing processes Write and perform process validations Make recommendations for equipment purchases based upon manufacturing needs Perform IQ/OQ/PQ as required on equipment Disposition NCRs and CAPAs as assigned Perform experiments including but not limited to DOEs to characterize and improve processes Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis Coordinate with suppliers and external resources needed in developing and implementing new processes Work closely with Manufacturing to capture and interpret design intent in order to refine and improve processes Facilitate excellent communications between all team members Responsible for communicating business related issues or opportunities to next management level For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable markets Performs other duties assigned as needed.

Title: Quality Engineer – NPD

Location: Los Gatos, CA

Length: 6+ months

Details: Client needs an additional QE with heavy NPD experience to work on site (or remote hybrid) in Los Gatos, CA. Will be supporting new product development and NPD transfers and responsible for process engineering and improvement, yield improvement, cost reductions, mechanical and electrical assembly, troubleshooting where needed, and various other projects including but not limited to the testing and design of toolings, requirements, and validation protocols. Knowledge of drafting software systems such as AutoCad and Solidworks (or equivalent) is required.

Title: Quality Engineer

Location: Louisville, KY (remote hybrid after first few months)

Length: 12-18 months w/ chance to go perm

Details: Client needs someone to act as their representation and work with 3rd party vendors at a distribution center in KY. Will need to go through inspection records, drawings, and data to make sure they meet specs and provide guidance if they don’t. Looking for someone with 3-5 years’ experience in medical device. Must have experience in Risk Mgmt, FMEA, Inspection Records, NCR, and continuous improvement but some coaching can be provided if needed.

Title: Manufacturing NPI Engineer

Location: Milpitas, CA

Length: 12 months

Details: Consultant will be working as an R&D, Sustaining, New Product Introduction Engineer. They have a new product line coming from R&D to this site. They are only doing the Pilot lines, or small scale production at this site. Once established they will then send to Baja, Mexico.

Manager needs a consultant with R&D/NPI with Solidworks to help construct the small scale pilot lines of "Capital Equipment" for eye laser. Client has many product lines at this site related to cataract removal, prepping the eye for LASIK surgery, prepping the lens of the eye, etc. so their will be laser and optics components to the Capital Equipment. The consultant must be able to read Engineering Drawings and use Solidworks for the Tooling and Fixtures.

• Analyzes and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a major breakthrough in technology.
• Understands engineering principles theories, concepts, practices and techniques. Recognized leader or authority in an area of specialization and applies this knowledge in leadership roles.
• • Provides support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met.
• Manufacturing engineering in Medical device manufacturing experience or semiconductor capital equipment
• Knowledge of ISO and FDA requirements as they relate to manufacturing.
• Must be a hands-on problem solver.
• Must be able to work effectively in a cross-functional team.
• Must have excellent written and oral communication skills.
• Knowledge of MD equipment qualifications: IQ, OQ, PQ and V&V
• To be able to create tech reports and/or protocols for qualifications

Title: Sr. Technical Writer

Location: Boulder, CO (remote hybrid after first couple months)

Length: 6 months

Details: Consultant will be responsible for converting 20-30 paper based batch record documents and uploading them to Master Control for EBR. Will also be responsible for review and approving batch records and to create 15-20 templates in MC.

Experience: API background, understanding of GMP Quality Systems, strong technical writing skills.

On site for first couple month to get acquainted and upload paper based documents into MC then can work remote to update docs and go on site as needed.

Thanks & regards,

Process Engineer About The Role We are looking for a motivated, collaborative and creative individual to join our rapidly growing and high-performing Peripheral Interventions team. You will have the opportunity to drive innovative technology solutions from concept to commercial. You will be partnering cross-functionally with a technically strong, experienced, and highly engaged team. Your Responsibilities Include

• As a key member of the New Product Development team you will apply technical knowledge to innovate, design & develop processes, and advance emerging technology.
• Collaborates & partners with R&D to develop product concepts, influence design specifications and provide Design for Manufacturability (DFM) input to the engineering print package.
• Works cross functionally to own, develop, & deliver capable and robust processes and equipment to operations.
• Develops experimental strategy and presents technical data and recommendations at technical reviews.
• Develop, write, & review process validation strategy and related deliverables to meet quality system requirements. (e.g., Experiment tech reports, GR&R, TMV, IQ, FMEA’s, etc.)
• Contributes ideas to or generates Intellectual Property submissions.

Minimum Qualifications What we’re looking for:

• 2 years of experience
• BS in Engineering
• Industry related experience (internships, co-ops also acceptable)

Preferred Qualifications

• Excels in a collaborative, cross-site environment.
• Expertise in New Product Development
• Demonstrated cross functional teamwork in technical environment
• Medical device or other regulated industry experience.
• Demonstrated understanding and usage of statistics to drive improvements.
• Strong mechanical aptitude. Fixture and equipment design or trouble shooting experience (CAD experience not required).
• Open to travel of up to 10% of their time.

Job Title: QC Analyst (HPLC/ Q-PCR)

Location: Lexington, MA

Length of Assignment: 1 year

Job Description:

There are 3 roles here:

1 is regular day shift (This can be a slightly lower level person)

2 are second shift 1PM-10PM (These need to be 8-10 year people)

The focus will be Q-PCR, HPLC and Lab GMP

• Perform routine/non-routine testing of in-process, final product, raw material samples in accordance with Standard Operating Procedures such as Q-PCR, Cell Based Potency Assay, Infectivity, Western Blot, Refractometry, HPLC/SEC, Osmolality, ELISA, etc.
• Aseptic technique and working with cell culture and live viruses.
• Participate in the execution of equipment validation, method validation, and qualification protocols.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Maintain QC lab and related systems to ensure compliance with industry standards.
• Assist with data trending and aid in compilation of trend reports.
• Responsible for change control and deviation related to QC operations, including assisting with LIs, OOSs, and OOTs.

Mechanical design Engineer - PA Design experience using Solid works, AutoCAD.  

• Candidates with 2 Year exp, MS freshers with prior around 2-year experience OPT candidates 

 

• Experience in Mechanical products design & development.
• Knowledge in Machined components, Sheet metal parts and Detailing.
• Knowledge of drafting standards, ASME Y 14.5 GD&T standard.
• Experience in SAP PLM system. 
• Knowledge of Engineering change notifications and implementing changes ECR/ECO/ECN.
• Understanding of manufacturing process and tolerance. 
• Excellent verbal and written communication skills.
• Education requirements:  AAS Mechanical Engineering curriculum with applicable industry experience, BSME preferred.

 Job Responsibilities:

• Design of semiconductor equipment’s subsystems and parts
• Interface with operations and electrical, process and software engineering.
• Generate and modify Bill of Materials, ECO release.
• Communicate and give direction to manufacturing personnel during build process.
• Continually develop design standards to increase efficiency of the design and build processes.
• Produce clear and accurate documentation in a timely manner.

TITLE: CQV Engineer LOCATION: Boston, MA DURATION: LongTerm Contract   POSITION SUMMARY:

• As our Quality Assurance Validation Engineer, Cell Therapy, you will be responsible for providing Quality oversight to Commissioning, Qualification and Validation (CQV) activities and change control for the startup of a new equipment
• Provides document review and approval for facility, equipment, and utility commissioning and qualification, process validation, computer system and analytical validation documentation to ensure compliance with policies and procedures
• Ensures that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence
• Reviews and approves protocol discrepancies associated with the qualification and startup of the Devens Cell Therapy Facility
• Supports the administration and maintenance of the site change control system, assuring consistency with establishing standards for local and global change control systems
• Provides quality oversight for calibration and maintenance activities
• Identifies unresolved issues/decisions related to validation documents and escalates, as appropriate
• Demonstrates appropriate examples for compliance behaviors and attitudes
• Meets and exceeds all safety expectations and adheres to all BMS behaviors
• Seeks opportunities for continuous improvement
• Assists in responding to inquiries from audits and inspections from world health authorities
• Provides Quality oversight on Technology Transfer initiatives
• Verifies compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications

Job Description: Demonstrated expertise with complex mechanical engineering solutions. Experience in design and developing some or all of the following types of products is desirable: electromechanical actuators and motors, fluid power actuation and controls, pneumatic values, aircraft jet engine accessories and controls. Able to lead assembly, development, and qualification testing, while engaging closing with manufacturing and laboratory teams. Able to act as a technical lead for a project, providing knowledge and expertise for colleagues. Proficient in understanding and working with multi-generational design practices (2-D drawings, CAD and 3-D modeling and drawings). Familiar with structural and performance analysis techniques and able to execute design level rough analyses. Ability to improve products or services by applying professional and business knowledge. Effective interpersonal, verbal and written communication skills to drive tasks to completion. Familiarity with new product development practices applicable in an aerospace industry environment. Capable mentor, able to check others' designs and able to manage / integrate a package of drawings. • Has good command of basic engineering principles required for products. • Excellent written and verbal communication skills. • Customer service orientation and strong history of customer engagement. • Good interpersonal skills and team leadership potential strong cross-functional awareness/knowledge and (preferred) direct experience. • Strong prioritization skills and able to handle multi-tasking, • Decision making skills, even with incomplete information. • Self-directed; capable of acting independently to design and develop assigned products. • Possesses knowledge of customers / suppliers in aerospace engine systems and components. • Integrated Product Team level technical leadership experience.   Desired Skills: Develop design concepts for modulating and on/off valves and actuators used in bleed air and environmental control systems of airplanes. Provide mechanical design expertise to develop new products and/or to support improving existing mechanical products; provide design review materials and lead design reviews where required. Calculate force margins, perform simple stress analysis, and size valve/actuation components. Lead projects and integrated project teams through the full new product introduction lifecycle, in compliance with company standard procedures and industry best practices. Meet cost, schedule, and specification constraints (including product design to cost goals) for new product introduction and/or achieve higher manufacturing yield, resolve customer product concerns, and address post-qualification requirement changes. Maintain project files and appropriate records of work, compliant with company and aerospace industry standards, practices, and regulations. Reduce development costs and improve design and development processes, using best practices and professional knowledge. Support site operations and other business objectives as required.

Role: Mechanical Design Engineer Location: Horsham, PA Duration : 12 months   Skills:

• Candidate must be a current user of AutoCAD, minimum AutoCAD LT 2013 or better.
• Candidate must have a minimum of 5 years AutoCAD 2D experience.
• Candidate must be a current user of SolidWorks, minimum 2015 Edition.  PDM experience required a plus.
• Candidate must have a minimum of 3 years SolidWorks experience.
• Must be able to multitask and handle multiple projects at any one time.
• Must be able to communicate effectively, written and verbally.
• Must be able to work with minimal supervision.
• Must be proficient using Microsoft Excel.
• Should have experience in using Microsoft Dynamics AX, SAP or similar MRP systems.
• Ability to read and understand Plumbing and Instrumentation Diagram’s (P&ID)
• Should be familiar with plumbing system design using standard and custom components used in high purity gas and wet chemical processing equipment (valves, fittings, etc.)
• Should be skilled in standard drafting practices in SolidWorks, including part detailing and tolerancing (ANSI Y14).
• Familiar with sheet metal parts and fabrication.
• Experience in designing equipment used in a cleanroom environment a plus.
• Education requirements:  AAS Mechanical Engineering curriculum with applicable industry experience, BSME preferred.

  Job Responsibilities:

• Package plumbing components per P&ID Piping and Instrumentation Diagram (P&ID) using Veeco PSP standards and procedures.
• Generate and modify Bill of Materials.
• Interface with operations and electrical, process and software engineering.
• Communicate and give direction to manufacturing personnel during build process.
• Continually develop design standards to increase efficiency of the design and build processes.
• Produce clear and accurate documentation in a timely manner.

• Must adhere to various industry standards.

Role: Project Engineer 1 Location: CA   Excellent ability to apply a systematic, disciplined and analytical approach to problem solving Strong knowledge of CAD and SolidWorks modeling Ability to use existing procedures to solve problems Good knowledge and ability to apply core concepts of engineering (mechanics, kinematics, thermodynamics, materials science, structural analysis and electricity) Effective interpersonal, verbal and written communication skills to drive tasks to completion   Desired Skills Technical / Soft Skills Provides expertise in the design, development and testing of mechanical components Performs mechanical component development and integration; uses Computer-Aided-Design (CAD)concepts and applicable methods and procedures Participates in engineering activities to define product requirements, creates designs, performs simulation testing and validation of final hardware components Performs mechanical development and integration assignments Conducts value analysis during the product design phase while optimizing development costs Solves technical problems and improves existing designs Consistent exercise of independent judgment and discretion in matters of significance. Regular, consistent and punctual attendance is required. May need to work nights and weekends, variable schedule(s) and additional hours as necessary

Regulatory engineer, Regulatory Specialist, RA Specialist or RA Engineer - Location: Mounds View, MN 12-24 months; contract to hire or full time • 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