Responsibilities

• Develop and execute commissioning protocols.
• Perform Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform process, cleaning, and computer systems validation.
• Prepare validation plans, protocols, reports, and traceability documentation.
• Ensure compliance with FDA, GMP, and regulatory requirements.
• Participate in risk assessments and mitigation planning.
• Collaborate with Quality, Manufacturing, Engineering, and Regulatory teams.
• Support startup, equipment walkdowns, and troubleshooting.
• Identify and implement continuous improvement opportunities.

Must-Have Skills, Experience, and Education

• Bachelor's degree in engineering, Life Sciences, or related field.
• 3-5 years of CQV experience in an FDA-regulated manufacturing environment.
• Experience with FAT, SAT, IQ, OQ, PQ, URS, P&IDs, equipment startup, and validation.
• Strong understanding of GMP and FDA regulations.
• Excellent technical writing and documentation skills.
• Ability to travel 50-70%.

Nice-to-Have Skills

• Biotech manufacturing
• Aseptic processing
• Fill/Finish
• Gene Therapy
• GMP
• FDA compliance
• CQV
• Validation software
• ASQ Certified Quality Engineer
• Pharmaceutical manufacturing