Quality Engineer (Biotech)

Location: Pomona, United States; must be authorized to work in the U.S.

Salary: $110,000–$120,000 annually

Company

hirify.global provides consulting and professional services to clients through a global team supporting regulated pharmaceutical, biotechnology, and medical device environments.

What you will do

• Review and approve validation documentation for accuracy, completeness, traceability, and technical adequacy.
• Ensure validation records comply with internal procedures, GMP requirements, and regulatory expectations.
• Identify documentation deficiencies and collaborate with Validation, Engineering, Manufacturing, and Quality teams to resolve them.
• Review and approve deviations, investigations, CAPAs, and change controls associated with validation activities.
• Verify that validation deliverables are properly documented, approved, maintained, and inspection-ready.
• Support audits, regulatory inspections, and continuous improvement initiatives related to validation documentation and quality systems.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality Assurance, or a related scientific discipline.
• At least 5 years of experience in Quality Assurance, Validation, or validation document review within a regulated GMP environment.
• Experience reviewing and approving validation documentation, including IQ/OQ/PQ protocols and reports, risk assessments, and change controls.
• Working knowledge of FDA, EU GMP, and ICH requirements.
• Experience with deviation management, CAPA, change control, and document management systems.
• Must be authorized to work in the U.S.; C2C arrangements are not available.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• 401(k) plan with matching.
• PTO, sick time, and paid holidays.
• Employee assistance, life insurance, and short- and long-term disability options.
• Education assistance, pet insurance, fitness discounts, and financial perks.