Lab Instrument Validation Engineer
Edison-New Brunswick Metro Area, NJ
- Laboratory Instrumentation Validation Engineer
- Summary: supports the successful implementation of laboratory equipment at multi-use sites through interaction with internal customers and external service providers. Contributes to the completion of milestones associated with equipment qualification.
- Supports laboratory equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- 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.
- Requirements - BS Degree in Chemistry, Engineering, or related with 5 years of experience in pharmaceutical industry
- 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, etc
Experience executing equipment qualification documents
Ability to interact effectively with laboratory, QA, and Facilities groups