Validation and Maintenance Engineer (Cranbury, NJ)

Analyze, validate, and provide engineering support to electronically controlled manufacturing production line and equipment for pharmaceutical drug manufacturing to ensure machines perform at optimum level to meet production, safety, and regulation targets applying principles of electrical engineering, electronic automation, embedded software in electronically controlled PLC based precision machinery, and validation; Design and develop engineering protocols for the installation, evaluation, maintenance, and calibration of new manufacturing machines; Analyze Building Management System (BMS); Prepare URS/IQ/OQ/PQ validation protocols for equipment, utility systems in compliance with FDA, WHO; Prepare Change Control, Deviation Reports, CAPA, SOPs, and cGMP compliance documentation; Develop maintenance SOPs to train maintenance mechanics on new systems; Supervise 1 maintenance mechanic.

Requirements

Must have a Master’s Degree or its equivalent (Bachelor’s degree plus 5 years experience inclusive of 2 years experience in job offered or as Executive Maintenance in pharmaceutical industry) in Electronics Engineering, Electrical Engineering, or Computer Engineering plus 2 years experience in job offered or as Executive Maintenance in pharmaceutical industry. Require skills and knowledge in PLC, URS, WHO, BMS, IQ/OQ/PQ, CAPA, cGMP.

Job Location

Cranbury (NJ)

Address: Eywa Pharma Inc., 2 Research Way, Floor 3, Princeton, NJ 08540.