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 systemsSupports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipmentSupervises vendors for qualification functionsQualifications of the Engineer:

6+ years experience in FDA-regulated industry performing IQ/OQ/PQ functions or writing protocols/URSExcellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industryWorking knowledge of ISPE guidance and 21 CFR Part 11 complianceBS in Engineering/Science or equivalentCompensation for the Engineer:

$120,000 salary; full-timeComprehensive 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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