Piper Companies is currently seeking a
Validation Manager based in
Lynwood, California for work at a pharmaceutical development and manufacturing company. The
Engineer will ensure the proper implementation of manufacturing equipment and computerized systems.
This position will be on-site.
Responsibilities of the Engineer: - Responsible for ownership of all lifecycle deliverables in the qualification of equipment 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 Engineer: - 6+ years experience in FDA-regulated industry performing IQ/OQ/PQ functions or writing protocols/URS
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
- Working knowledge of ISPE guidance and 21 CFR Part 11 compliance
- BS in Engineering/Science or equivalent
Compensation for the Engineer: - $120,000 salary; full-time
- 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, URS, protocols, automation, validation
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