Senior Validation Engineer (I, II, III)

Location: Bridgewater, New Jersey, United States; on-site

Company

hirify.global develops proprietary equipment and manufacturing systems for cell and gene therapy operations.

What you will do

• Execute qualification and validation activities for QC and manufacturing equipment, including hirify.global Cell Shuttle and Cell Q systems.
• Execute validation activities for facility and utility systems in GMP-regulated environments.
• Develop and review SOPs, risk assessments, system impact assessments, validation master plans, URS, IQ/OQ/PQ protocols, project plans, validation master lists, and summary reports.
• Maintain validated status through periodic reviews, requalification, change control, and impact assessments for equipment and software or hardware changes.
• Oversee contractors, junior engineers, and equipment vendors supporting commissioning, qualification, and validation projects.
• Identify validation gaps, drive mitigation plans, mentor junior engineers, support continuous improvement, and participate in regulatory inspections.

Requirements

• Bachelor’s degree in Engineering or a related scientific field and at least 8 years of experience in a GMP-regulated environment.
• At least 5 years of hands-on qualification and validation experience.
• Knowledge of 21 CFR Parts 210, 211, and 820, EU GMP Annex 1, GAMP5, System Development Life Cycle concepts, and 21 CFR Part 11.
• Understanding of CSV methodology, risk-based validation, data integrity, ALCOA+ principles, and QC equipment validation.
• Excellent technical writing skills and understanding of good documentation practices.
• Collaborative, self-motivated, detail-oriented, and comfortable working in a fast-paced, agile environment.

Culture & Benefits

• Mission-driven work focused on advancing cell therapies.
• Collaborative, solution-oriented environment with cross-functional teams.
• Opportunity to contribute to validation harmonization across hirify.global sites.
• Leveling is based on experience, education, and demonstrated knowledge during the interview process.