Validation Engineer II (Pharmaceutical Manufacturing)
The Validation Engineer II for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities. This resource have to ensure compliance with industry standards and regulatory requirements while working closely with cross-functional teams to support new installations, system upgrades, and operational readiness.
Location: Houston
Onsite: Mon - Fri 5x; 1st shift
Contract Length: 6 months; *W2 contract only, no C2C
Qualifications:
- 3-5 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.
- Hands-on experience with systems such as HVAC, purified water, clean steam, gases, and cleanrooms.
- Kneat experience
- Familiarity with environmental monitoring and building management systems (BMS)
Key Responsibilities:
- Plan and execute commissioning activities for utility systems (e.g., HVAC, purified water systems, clean steam, compressed gases) and facilities (e.g., cleanrooms, environmental monitoring systems).
- Troubleshoot and resolve technical issues during the commissioning phase.
- Author, execute, and review qualification protocols (IQ, OQ, PQ) for utilities and facilities.
- Validate critical systems, including HVAC balancing, environmental monitoring, water quality testing, and cleanroom certification.
- Perform thermal mapping, pressure testing, and other critical tests as needed.
- Document deviations, CAPAs, and change controls associated with facilities and utilities systems.
- Ensure traceability of qualification activities in alignment with the Validation Master Plan (VMP).
- Ensure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).
- Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.
Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.
If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.
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