Validation Engineer II (Biopharmaceutical Validation)

Location: El Segundo, California, United States; on-site

Salary: $103,500–$115,000 annual base pay, plus discretionary bonus and equity award

Company

hirify.global is a publicly traded biopharmaceutical company developing cell and immunotherapy products, vaccines, and therapies designed to harness and strengthen the immune system against cancer and infectious diseases.

What you will do

• Generate, support, and execute validation protocols, including IQ, OQ, PQ, CV, and PV, for laboratory and production equipment, facilities, utilities, processes, and automation systems.
• Author and review SOPs, protocols, summary reports, validation master plans, and documentation for GMP equipment, instruments, and computerized systems.
• Coordinate validation activities with cross-functional departments, clients, contract manufacturing organizations, vendors, and other stakeholders.
• Maintain GMP system inventories and requalification or periodic review schedules.
• Perform and lead risk assessments, plan validation activities according to risk, and support facility commissioning.
• Troubleshoot and resolve discrepancies identified during validation and qualification activities.

Requirements

• Bachelor’s degree in science or a related discipline.
• At least 3 years of relevant validation or GMP-regulated industry experience.
• Experience with facility commissioning and validation of equipment and facilities.
• Working knowledge of validation principles, commissioning, IQ/OQ/PQ, GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, and automated biopharmaceutical processing and plant equipment.
• Working knowledge of 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. The role also requires frequent lifting of up to 35 pounds and occasional lifting or moving of up to 50 pounds.

Culture & Benefits

• Collaborative environment with cross-functional work across different areas of the company.
• Professional development opportunities in a growing biopharmaceutical organization.
• Medical, dental, and vision plan options, along with health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability insurance, and an employee assistance program.
• Paid time off, including 11 holidays; exempt employees are eligible for unlimited PTO.
• Additional benefits include a 529 education savings program, legal services, identity theft protection, pet insurance, discounts, rewards, and perks.