Validation Engineer Position Available In Middlesex, New Jersey

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 inEngineering (Mechanical, Chemical, or related field). Minimum 4years of experience in facilities validation, commissioning, andqualification (CQV) in the pharmaceutical or biopharmaceuticalindustry. Hands-on experience developing and executing IQ/OQ/PQprotocols for HVAC, water systems (WFI/RO/DI), clean steam,compressed air, or air handling systems inpharmaceutical/biopharmaceutical manufacturing environment.

Experience with WFI

• Water for Injection, RO
• Reverse Osmosis, DI
• Deionized Water, a big plus Strong knowledge of

FDA, EU GMP, ICHQ7, ISPE

Baseline Guides, and USP requirements for facilities andutilities in pharmaceutical and biopharmaceutical production.

Experience with

GAMP 5, 21 CFR

Part 11 compliance, and electronicdata integrity regulations. Familiarity with automatedenvironmental monitoring systems (EMS), SCADA, BMS, and PLC-basedutility control systems is a plus. Excellent technical writing,documentation, and risk assessment skills.

Responsibilities:

Develop and execute validation protocols (IQ/OQ/PQ) for criticalutilities and environmental systems within pharmaceutical andbiopharmaceutical manufacturing environments, including HVAC,purified water systems (WFI, RO, DI), clean steam, compressed air,and air purification systems. Perform facilities, utilities, andequipment commissioning, qualification, and validation (CQV) toensure regulatory compliance in GMP manufacturing settings. Conductrisk assessments (FMEA, hazard analysis) and develop mitigationstrategies to maintain compliance with

FDA/EU GMP

regulations forpharmaceutical and biopharmaceutical operations. Perform GAPanalysis on existing facilities and utilities, providingremediation 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 processchanges by ensuring proper qualification and validation forpharmaceutical and biopharmaceutical production. Author validationmaster plans, protocols, reports, and standard operating procedures(SOPs) for cleanroom environments and biologics manufacturingfacilities. Work cross-functionally with engineering, quality,maintenance, and operations teams to troubleshoot validationchallenges and implement continuous improvement initiatives inpharmaceutical and biopharmaceutical facilities. Ensuretemperature, humidity, and environmental monitoring systems areproperly qualified and validated for GMP compliance. Leadvalidation deviation investigations and develop corrective andpreventive action (CAPA) plans.

Benefits:

System One offerseligible employees health and welfare benefits coverage options,including medical, dental, vision, spending accounts, lifeinsurance, voluntary plans, and participation in a 401(k) plan.

Ref:

558-Scientific