Description

• Design, Develop and Implement validation of different moderately complex to complex manufacturing and laboratory equipment from installation to retirement by following GxP practices, company procedures and regulatory requirements
• Provide technical and operational support (procedural) for the use of equipment, develop and execute IQ/OQ protocols and performance specific process related qualification documents to validate the equipment to ensure they meet regulatory requirements and process specifications per manufacturing products
• Perform Design of Experiment and research for the parametric change of the parameters that play key role in high volume manufacturing in a production environment. Write and execute validation protocols by collaborating with quality control and product engineering team to meet the quality standards as per FDA regulations to develop suitable test methods and associated instruments
• Work with the SMEs, Quality Engineers and Product owners to gather User Requirements for the equipment, determine risk and develop and optimize product manufacturing related processes and associated process flow diagrams and Standard Operating procedures for shop-floor execution.
• Perform Risk management using ISO 14971 in the risk management program, including FMEA, risk reduction strategies by coordinating with quality team for better quality of the products and improve the validation and business processes.
• Execute qualification protocols including IQ/OQ/PQ to verify that the equipment have been installed, configured, and released for appropriate use. Validate the operators using the equipment have required training materials and complete training before use of equipment for safety and regulatory purpose.
• Work with Equipment manufacturers, vendors and technicians to review equipment turn-over-packages and coordinate planned and controlled execution of Site Acceptance tests and Engineering Change Controls. Gather, develop and prepare validation package for the cGMP equipment.
• Review Operator execution results, testing data results, temperature mapping reports to analyze and create data trends to identify potential risks, improvement opportunities and internal planning. Identify any existing deviations, perform risk and root-cause analysis and implement Corrective Action and Preventive Action to reduce the deviation from the actual process.
• Responsible for product life management (PLM) Agile environment by maintaining bill of materials (BOMs), guiding and mentoring less experienced engineers in initiating engineering change requests (ECR) and completing engineering change orders (ECO)

Work with the Management and cross-functional teams to determine the scope, schedule and drive successful closure of validation effort in time with business to ensure compliance with company procedures and FDA guidelines.

Bachelor’s Degree required in Science or related field.