CSV Engineer III (Computer System Validation)

Location: USA - OH - West Chester. On-site work across office, laboratory, and cGMP manufacturing environments, including cleanroom and manufacturing-floor activities. Monday–Friday, 8-hour schedule, with flexibility for production schedules, shutdowns, and time-sensitive validation work.

Salary: $85,000–$133,750 per year.

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.

What you will do

• Plan, author, and execute validation plans, IQ/OQ/PQ protocols, and summary reports for automation and computerized systems.
• Lead qualification and lifecycle management of PLC, SCADA, DCS, and other GxP computer systems.
• Develop risk-based validation strategies across facility, utility, process, cleaning, automation, and computer system portfolios.
• Lead validation studies and investigations, resolve complex issues, and communicate project priorities, risks, and progress.
• Maintain validated states through change control, periodic review, requalification, corrective actions, and audit-ready documentation.
• Coach engineers and technicians and align engineering, quality, and operations on validation requirements and acceptance criteria.

Requirements

• Experience in validation or process engineering, including independently leading validation studies and projects.
• Hands-on experience with automation and computer system validation.
• Knowledge of GxP, cGMP, 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity principles.
• Ability to interpret engineering drawings, P&IDs, and system diagrams, with strong analytical, documentation, communication, and problem-solving skills.
• Ability to manage concurrent projects independently and provide technical guidance to less-experienced team members.
• Visa and work authorization sponsorship or support is not available.

Nice to have

• Bachelor’s degree in Engineering, Computer Science, or a related discipline.
• 5+ years of validation or process engineering experience.
• Experience in regulated or cGMP manufacturing environments.
• Knowledge of SDLC, configuration management, scripting, automated testing tools, and validation lifecycle management software.
• Experience with Rockwell/Allen-Bradley, Siemens, or Emerson DeltaV PLC/SCADA/DCS platforms and data historians.

Culture & Benefits

• Annual cash bonus program.
• 401(k) plan with company match.
• Medical, dental, and vision coverage, plus life and disability insurance.
• Paid vacation, holidays, and other leaves of absence.
• Tuition reimbursement and caregiving support.
• Cleanroom, PPE, and safety requirements apply in manufacturing areas.