🔬 Validation Engineer II - Utilities & Facilities (Contract)

📍 Onsite | 1st Shift (Mon-Fri)
⏳ Contract: 3-6 Months (Initial 3-Month Assignment)

We are seeking a Validation Engineer II to support commissioning, qualification, and validation activities for utilities and facility systems within a GMP-regulated pharmaceutical or biotech environment. This is a high-impact, fully onsite role ideal for someone who thrives in fast-paced project environments and takes ownership of validation deliverables from execution through compliance.

🔧 Key Responsibilities

Commissioning & Startup

• Execute commissioning activities for critical systems including HVAC, purified water, clean steam, and compressed gases
• Troubleshoot technical issues and support operational readiness

Qualification & Validation (CQV)

• Author and execute IQ/OQ/PQ protocols for utilities and facility systems
• Perform validation activities such as HVAC balancing, thermal mapping, and cleanroom certification
• Ensure systems meet performance requirements and GMP standards

Documentation & Compliance

• Develop validation documentation including protocols, reports, and SOPs
• Support deviation investigations, CAPAs, and change control processes in line with GMP expectations
• Maintain traceability aligned with Validation Master Plans (VMPs)

Regulatory & Risk Management

• Ensure compliance with regulatory standards (FDA, EMA, WHO, 21 CFR Part 11)
• Conduct risk assessments and implement mitigation strategies

✅ Qualifications

• 3-5 years of experience in CQV for utilities and facilities in GMP environments
• Hands-on experience with systems such as:
  • HVAC
  • Purified Water (WFI, RO/DI)
  • Clean steam, compressed gases
  • Cleanrooms & environmental monitoring
• Experience authoring/executing validation protocols (IQ/OQ/PQ)
• Familiarity with Kneat or electronic validation systems preferred
• Strong knowledge of cGMP and validation lifecycle practices

🏭 Work Environment

• Onsite in a manufacturing/utility setting, including cleanrooms
• Flexibility to support extended hours during critical project phases

🚀 Why Apply?

This is a great opportunity to contribute to critical facility startup and validation efforts, working cross-functionally with engineering, QA, and operations teams to ensure systems are inspection-ready and compliant from day one.