CQV Engineer III (Biotech)

Location: Onsite in Oceanside, California, United States

Salary: $100,000–$130,000 annually

Company

hirify.global is an employee-owned international project delivery firm supporting pharmaceutical, food, biotech, medical technology, and mission-critical projects through outsourced technical services.

What you will do

• Execute commissioning, qualification, and validation activities for equipment, facilities, utilities, and systems.
• Develop qualification documentation, commissioning pre-functional checklists, functional performance testing, and technical and scientific reports.
• Perform quality gap analyses and assess client qualification needs, including user requirements specifications and system impact analyses.
• Conduct and review qualification protocols, vendor documentation, FAT/SAT activities, and cleaning validation procedures.
• Ensure compliance with current good documentation, engineering, and manufacturing practices.
• Interact with clients, manage scope within budgeted hours, collaborate across disciplines, and provide technical guidance 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, or cell and gene therapy industries.
• Experience with FAT, SAT, PFC development, FPT, qualification testing, validation life cycles, and change control.
• Experience in regulated life sciences and cGMP manufacturing environments.
• Knowledge of design drawings, vendor-supplied documents, submittal sheets, and turnover packages.
• Strong technical report-writing skills and willingness to travel as needed for client development and project execution.

Culture & Benefits

• Employee-owned company with an inclusive workplace focused on mutual respect and belonging.
• Opportunities to support clients across the complete project life cycle.
• Commitment to corporate responsibility and sustainability.
• Reasonable accommodations are available during the recruitment process for candidates with disabilities.