Snr Validation Associate
Newark Metro Area, New Jersey
- BS degree in Engineering or equivalent
Minimum 5 years of experience in FDA-regulated industry, with 3 year experience in equipment qualification.
- Equipment Engineer supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with equipment qualification. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Maintains all qualified equipment systems in compliance with policies, guidelines and procedures.
Develops qualification protocols, and associated reports while adhering to a change management process.
Supports the execution of equipment qualifications and validation protocols
Supervises vendors for qualification functions.
Develops written procedures for calibration and preventive maintenance of equipment
Supports calibration, equipment qualification and validation activities.
Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls.
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
Familiarity with 21 CFR Part 11 compliance
Knowledge of pharmaceutical laboratory and manufacturing systems. Preferred experience with Kaye validators, BSCs, refrigerators, welders, etc.