Validation Engineer
Location: Piscataway
Posted on: June 23, 2025
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Job Description:
Job Title: Validation Engineer Location: Piscataway, NJ Hours /
Schedule: Monday - Friday, 8 AM - 5 PM (some flexibility required)
Type: Contract-to-Hire/ Direct Hire Must Haves: BS or MS in
Engineering (Mechanical, Chemical, or related field). Minimum 4
years of experience in facilities validation, commissioning, and
qualification (CQV) in the pharmaceutical or biopharmaceutical
industry. Hands-on experience developing and executing IQ/OQ/PQ
protocols for HVAC, water systems (WFI/RO/DI), clean steam,
compressed air, or air handling systems in
pharmaceutical/biopharmaceutical manufacturing environment.
Experience with WFI - Water for Injection, RO - Reverse Osmosis, DI
- Deionized Water, a big plus Strong knowledge of FDA, EU GMP, ICH
Q7, ISPE Baseline Guides, and USP requirements for facilities and
utilities in pharmaceutical and biopharmaceutical production.
Experience with GAMP 5, 21 CFR Part 11 compliance, and electronic
data integrity regulations. Familiarity with automated
environmental monitoring systems (EMS), SCADA, BMS, and PLC-based
utility control systems is a plus. Excellent technical writing,
documentation, and risk assessment skills. Responsibilities:
Develop and execute validation protocols (IQ/OQ/PQ) for critical
utilities and environmental systems within pharmaceutical and
biopharmaceutical manufacturing environments, including HVAC,
purified water systems (WFI, RO, DI), clean steam, compressed air,
and air purification systems. Perform facilities, utilities, and
equipment commissioning, qualification, and validation (CQV) to
ensure regulatory compliance in GMP manufacturing settings. Conduct
risk assessments (FMEA, hazard analysis) and develop mitigation
strategies to maintain compliance with FDA/EU GMP regulations for
pharmaceutical and biopharmaceutical operations. Perform GAP
analysis on existing facilities and utilities, providing
remediation strategies to meet the latest regulatory expectations,
including 21 CFR Part 210/211, ICH Q7, and ISPE Baseline Guides.
Support facility modifications, new installations, and process
changes by ensuring proper qualification and validation for
pharmaceutical and biopharmaceutical production. Author validation
master plans, protocols, reports, and standard operating procedures
(SOPs) for cleanroom environments and biologics manufacturing
facilities. Work cross-functionally with engineering, quality,
maintenance, and operations teams to troubleshoot validation
challenges and implement continuous improvement initiatives in
pharmaceutical and biopharmaceutical facilities. Ensure
temperature, humidity, and environmental monitoring systems are
properly qualified and validated for GMP compliance. Lead
validation deviation investigations and develop corrective and
preventive action (CAPA) plans. Benefits: System One offers
eligible employees health and welfare benefits coverage options,
including medical, dental, vision, spending accounts, life
insurance, voluntary plans, and participation in a 401(k) plan.
Ref: 558-Scientific
Keywords: , East Brunswick , Validation Engineer, Science, Research & Development , Piscataway, New Jersey
