Principal Validation Engineer (Biopharma)

Location: On site in El Segundo, California, United States

Annual base pay: $148,500–$165,000, plus eligibility for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded biopharmaceutical company developing cell and immunotherapy products, vaccines, and next-generation treatments for cancer and infectious diseases.

What you will do

• Coordinate validation activities across affected departments, personnel, contractors, clients, contract manufacturing organizations, and vendors.
• Define validation requirements, design strategies, verification plans, and validation plans with cross-functional teams.
• Generate and execute IQ/OQ/PQ protocols for laboratory and production equipment, utilities, facilities, instruments, and computerized systems.
• Author and review SOPs, protocols, reports, validation master plans, and GMP system documentation.
• Manage validation projects, schedules, contractors, shifting priorities, and delivery accountability.
• Lead troubleshooting, failure investigations, deviation and non-conformance resolution, requalification scheduling, audits, and regulatory inspections.

Requirements

• Bachelor’s degree in science or a related discipline.
• 10+ years of relevant validation or GMP-regulated industry experience.
• Experience with facility and equipment commissioning, qualification, and validation.
• Strong knowledge of validation principles, IQ/OQ/PQ, GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, and automated biopharmaceutical processing equipment.
• Experience with change control, CAPA, deviations/OOS, FMEA risk assessments, training, and document control.
• Ability to work on site and wear required personal protective equipment; the role includes lifting up to 35 pounds frequently and up to 50 pounds occasionally.

Nice to have

• Experience with ELLAB data loggers and systems.
• Working knowledge of Lean Six Sigma and/or Quality by Design approaches.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities in a growing biopharmaceutical organization.
• Medical, dental, vision, life, disability, and employee assistance program benefits.
• Healthcare and dependent care flexible spending accounts, 401(k) with company match, and a 529 education savings program.
• Paid time off, holidays, wellness programs, and additional voluntary services and employee discounts.