Validation Engineer III (Biopharmaceutical)

Location: Dunkirk, New York, United States; on-site

Salary: $115,500–$128,000 annually, plus discretionary bonus and equity award.

Company

hirify.global is a publicly traded, commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.

What you will do

• Lead validation activities for equipment, utilities, facilities, processes, automation systems, laboratory systems, and production systems.
• Generate, execute, review, and maintain IQ/OQ/PQ, commissioning, process validation, and related validation protocols and reports.
• Author and review SOPs, validation master plans, GMP documentation, system inventories, and requalification schedules.
• Perform risk assessments, troubleshoot discrepancies, and coordinate failure investigations for manufacturing and laboratory equipment.
• Collaborate with engineering, quality, operations, clients, CMOs, vendors, and contractors while overseeing project timelines and deliverables.
• Lead validation audits and regulatory inspections, train end users, and provide technical input for project planning.

Requirements

• Bachelor’s degree in science or a related discipline.
• 5+ years of relevant validation or GMP-regulated industry experience.
• Experience with facility commissioning and validation of equipment and facilities.
• Knowledge of validation principles, process validation, GMPs, OSHA compliance, 21 CFR Part 11, cleanrooms, and automated biopharmaceutical processing equipment.
• Experience with change control, CAPA, deviations/OOS investigations, training, and document control.
• Ability to work on-site in an in-lab environment and wear required PPE; frequent lifting of up to 35 pounds and occasional lifting or moving of up to 50 pounds is required.

Nice to have

• Experience with ELLAB data loggers and systems.
• Experience with project management concepts.
• Strong technical writing, communication, organizational, interpersonal, and teamwork skills.

Culture & Benefits

• Collaborative work across different areas of a growing biopharmaceutical company.
• Professional development opportunities.
• Medical, dental, and vision plan options, plus health and financial wellness programs.
• 401(k) retirement plan with company match, flexible spending accounts, disability coverage, and life insurance.
• Paid time off, holidays, education savings, legal services, identity theft protection, pet insurance, and employee discounts.