Job Description

Validation Engineer
Location: CA
Duration: 6 months

Key Responsibilities

• Lead and execute commissioning and qualification activities for equipment, utilities, and facilities (IQ, OQ, PQ).
• Develop and review validation documentation, including Validation Master Plans (VMPs), risk assessments, protocols, and summary reports.
• Support validation for HVAC, purified water, clean steam, process gases, and other critical utility systems.
• Perform CSV (Computer System Validation) activities for automation platforms and control systems.
• Ensure all validation work complies with GMP, FDA 21 CFR Part 11, and relevant industry standards.
• Participate in change control, deviation management, and CAPA processes to ensure validation state is maintained.
• Work with project teams during equipment start-up, FAT, SAT, and commissioning phases.
• Collaborate with QA and regulatory teams to support audits, inspections, and documentation reviews.
• Maintain detailed, compliant, and audit-ready validation records.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 3 7 years of validation experience in pharmaceutical, biotech, or medical device environments.
• Strong understanding of GMP, GEP, and CQV principles.
• Hands-on experience with utility systems (e.g., purified water, WFI, HVAC, compressed air, process gases).

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