Validation Manager

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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