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Job Title: Validation Engineer

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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.