We are seeking an Equipment Validation Engineer with 3-4 years of experience in the biopharmaceutical industry. The ideal candidate will have prior experience at Gilead or Kite Pharma and expertise in validation processes, qualification protocols, and compliance standards.
Key Responsibilities:
- Develop and execute IQ, OQ, PQ protocols.
- Ensure compliance with FDA, GMP, and regulatory standards.
- Perform validation lifecycle activities (URS, FMEA, risk assessments).
- Conduct deviation investigations and implement CAPAs.
- Maintain validation documentation and support audits.
- Collaborate with Quality, Engineering, and Manufacturing teams.
Requirements:
- 3-4 years of equipment validation experience in a GMP-regulated environment.
- Experience at Gilead or Kite Pharma (preferred).
- Strong knowledge of FDA 21 CFR Part 11, cGMP, and ICH guidelines.
- Hands-on experience with manufacturing, lab, and utility equipment validation.
- Strong documentation and compliance skills.
- Bachelor’s degree in Engineering, Life Sciences, or related field.
Preferred Qualifications:
- Experience with cell therapy or biotech processes.
- Strong understanding of risk-based validation approaches.
