Job Summary:

We are seeking a Validation Engineer – Clean Utilities to support the commissioning, qualification, and validation (CQV) of clean utility systems within a GMP pharmaceutical manufacturing environment. The ideal candidate will have experience with systems such as WFI, PW, Clean Steam, Compressed Gases, and HVAC, and be well-versed in regulatory requirements, validation protocols, and cGMPs.

Key Responsibilities:

• Lead and execute commissioning and qualification activities for clean utility systems
• Develop and review validation documentation (URS, FAT/SAT, IQ, OQ, PQ protocols and reports)
• Ensure compliance with cGMP, FDA, EU, and other relevant regulatory guidelines
• Support investigations and change control processes as related to validated systems
• Collaborate with cross-functional teams including engineering, QA, facilities, and manufacturing
• Conduct risk assessments and ensure robust validation lifecycle management

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 3–7 years of experience in validation engineering within the pharmaceutical or biotech industry
• Proven experience with clean utilities in a GMP environment
• Strong knowledge of validation regulations and industry guidance (FDA, EMA, ISPE)
• Aseptic/Sterile Pharmaceutical manufacturing experience
• Excellent communication, documentation, and organizational skills

Preferred Qualifications:

• Experience with new facility start-up or tech transfer projects