Senior Validation Engineer (Pharmaceutical Manufacturing)

Location: On premise in Rochester, Michigan, United States. Non-standard schedules, including weekends, second shifts, night shifts, or on-call support, may be required. Minimal travel for training and seminars. Relocation support may be available.

Annual base salary: $82,700–$137,900, plus eligibility for a 10% performance bonus.

Company

hirify.global operates the Rochester role in a penicillin manufacturing facility.

What you will do

• Plan, schedule, execute, and lead qualification, validation, and requalification activities for manufacturing processes, equipment, facilities, critical utilities, products, cleaning, shipping, aseptic processing, sterilization cycles, and laboratory equipment.
• Author and execute validation lifecycle documentation, including FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ, protocols, test scripts, reports, SOPs, programs, and validation master plans.
• Work with area owners, suppliers, and cross-functional departments to define requirements and complete validation activities.
• Investigate deviations, support corrective actions, perform gap and risk assessments, and assist with regulatory inspections, audits, and technical training.
• Perform periodic process capability analysis, identify improvement opportunities, review APQR sections, and assess change controls for impact on the validated state.
• Lead projects to reduce process risk and improve plant and process productivity.

Requirements

• Bachelor’s degree with at least 2 years of experience; or a master’s degree with 0+ years; or an associate’s degree with 6 years; or a high school diploma or equivalent with 8 years of relevant experience.
• Strong technical knowledge of validation and qualification for pharmaceutical processes, equipment, utilities, facilities, and/or computer systems is preferred.
• Experience with sterile products, medical devices, regulatory audits, and compliance is preferred.
• Ability to complete aseptic gowning and techniques qualification for Grade A through Grade D cleanroom environments.
• Must not be allergic to penicillin, must be able to aseptically gown, and must be able to lift 25–30 lbs.
• Permanent U.S. work authorization is required. U.S. work visa sponsorship is not available now or in the future.

Nice to have

• Strong analytical, problem-solving, organizational, and time-management skills.
• Ability to mentor and guide colleagues.
• Experience using generative AI tools such as ChatGPT or Microsoft Copilot for problem solving and productivity, with knowledge of responsible AI practices.

Culture & Benefits

• Full-time employment with comprehensive benefits.
• 401(k) plan with hirify.global matching contributions and an additional retirement savings contribution.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Performance plan eligibility with a 10% bonus target.