CQV Engineer III (Biotech)

TL;DR

CQV Engineer III (Biotech): Commissioning, Qualification, and Validation of equipment, facilities, and systems for life sciences clients with an accent on compliance with CGMP and QMS. Focus on performing GAP analysis, authoring technical reports, and executing qualification protocols including FAT, SAT, and FPT.

Location: Onsite in San Diego, California

Salary: $100,000 – $130,000 annually

Company

An employee-owned international project delivery firm specializing in pharma, biotech, medical technology, and mission-critical sectors.

What you will do

• Independently assess qualification needs for equipment, facilities, utilities, and systems.
• Perform quality GAP analysis and author technical and scientific reports.
• Develop and execute qualification protocols, including pre-functional checklists (PFC) and functional performance testing (FPT).
• Ensure the implementation of current good manufacturing practices (CGMP).
• Collaborate within multi-discipline teams to meet client qualification needs and budget constraints.
• Provide technical guidance and mentorship to less experienced CQV team members.

Requirements

• Bachelor’s degree required; an engineering degree is preferred.
• 5-10 years of CQV experience in Pharmaceutical, Life Sciences, Biotech, and/or Cell & Gene Therapy industries.
• Proven experience with Factory Site Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Deep understanding of the entire validation life cycle, change control processes, and cGMP environments.
• Proficiency in technical report writing and document approval processes.
• Ability to travel as needed for client development and project execution.

Culture & Benefits

• Employee-owned company structure promoting commitment and drive.
• Inclusive workplace culture centered on mutual respect, diversity, and belonging.
• Strong focus on corporate responsibility and sustainability (ESG).
• Fair and accessible hiring process with reasonable accommodations for candidates with disabilities.