Validation Engineer

Job Summary:
We are seeking a Validation Engineer – Utilities with 3-5 years of hands-on experience in commissioning, qualification, and validation (CQV) of critical utility systems within a pharmaceutical or biotech environment. This role is ideal for professionals experienced in ensuring systems meet GMP and regulatory compliance standards.

Key Responsibilities:
Execute and support IQ/OQ/PQ protocols for utility systems
Perform validation of critical systems including HVAC, PW/WFI, Clean Steam, Compressed Air, and Gas Systems
Participate in commissioning and qualification (C&Q) activities
Develop, review, and approve validation documentation (protocols, reports, SOPs)
Conduct risk assessments, deviation investigations, and implement corrective actions
Ensure compliance with GMP, FDA, and regulatory guidelines
Collaborate cross-functionally with Engineering, QA, and Operations teams

Required Qualifications
Bachelor’s degree in Engineering or related field
3–6 years of validation experience in pharma/biotech industry
Strong experience in utility systems validation
Solid understanding of GMP, GDP, and regulatory requirements
Excellent documentation and communication skills

Preferred Qualifications
Experience with cleanroom and facility qualification
Familiarity with risk-based validation methodologies
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