What are the responsibilities and job description for the Validation Engineer position at eTeam?
Title: Validation Engineer II
Location: Houston, TX 77047
Duration: 3 Months
Payrate: $35 - $57/an hr.
Mon - Fri 5x onsite 1st shift
Job Duties:
The Validation Resource 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.
Key Responsibilities:
1. Commissioning Activities
- 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.
2. Qualification & Validation
- 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.
- Ensure systems meet performance requirements and GMP standards.
- Perform thermal mapping, pressure testing, and other critical tests as needed.
3. Documentation
- Develop and maintain accurate and complete documentation, including protocols, validation reports, and SOPs.
- 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).
4. Compliance and Risk Management
- Ensure all utility and facility qualification activities meet global regulatory requirements (e.g., FDA, EMA, WHO).
- Perform risk assessments and develop mitigation strategies for utility and facility systems.
- Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.
Experience
- 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 (Client).
Working Conditions
- Manufacturing plant and utility environments, including cleanrooms.
- Flexibility to work extended hours or weekends during critical project phases.
Salary : $40 - $57