Validation Engineer I (Biopharma)

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

Annual base pay: $88,200–$98,000, depending on qualifications, experience, and geographic location.

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

• Generate, support, and execute validation protocols and summary reports for equipment, utilities, facilities, processes, and automation systems.
• Perform commissioning and validation activities for laboratory equipment, production equipment, utilities, and related GMP systems.
• Maintain inventories of GMP systems and requalification or periodic review schedules.
• Perform risk assessments and plan validation activities according to risk.
• Troubleshoot validation discrepancies and support senior engineers with resolutions.
• Collaborate with internal departments, clients, contract manufacturing organizations, and vendors on validation projects.

Requirements

• Bachelor’s degree in science or a related discipline.
• At least 1 year of relevant validation or GMP-regulated industry experience.
• Experience with facility commissioning and validation of equipment and facilities.
• Working knowledge of validation principles, including commissioning and IQ/OQ/PQ activities.
• Working knowledge of quality systems including change control, CAPA, deviations, OOS investigations, training, and document control.
• Ability to work on-site in an in-lab environment and wear required personal protective equipment.

Nice to have

• Technical document writing and review experience.
• Knowledge of GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, automated biopharmaceutical processing, and plant equipment.
• Strong communication, organizational, interpersonal, and teamwork skills.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities within a growing biopharmaceutical organization.
• Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability insurance, and education savings benefits.
• Paid time off, including 11 holidays, with vacation and health-pay provisions based on employee classification.
• Position is eligible for a discretionary bonus and equity award.