Piper Companies is currently seeking a Validation Engineer based in Summit, New Jersey for work at a leading pharmaceutical company. The Validation Engineer will interface with both internal customers and external service providers to ensure the proper implementation of manufacturing/laboratory equipment and computerized systems.
This position will start remote and transition to onsite once the site reopens.
Responsibilities of the Validation Engineer:
Responsible for ownership of all lifecycle deliverables in the qualification of equipment and full CSV for single and multi-user computerized systems
Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment
Supervises vendors for qualification functions
Qualifications of the Validation Engineer:
5+ years experience in FDA-regulated industry performing CSV
Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
Ability to work with the end user to identify and document User and Functional Requirements
BS in Engineering/Computer Science or equivalent
Compensation for the Validation Engineer:
Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO
Keywords: GMP, GLP, GXP, GCP, 21 cfr part 11, full-process manufacturing, CSV, Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls, FAT, SIT, final acceptance testing, system integration testing, engineering, computer engineering