Process Engineer III - Sterile Operations (Night Shift)

Location: West Chester, Ohio, United States; onsite sterile manufacturing environment

Salary: $80,000–$121,250 per year

Company

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

What you will do

• Lead process and equipment improvement initiatives across assigned sterile manufacturing processes, including changeover, yield, OEE, maintenance reliability, and waste reduction.
• Coordinate equipment capability, utilization, efficiency, obsolescence, asset life-cycle management, supplier relationships, and capital planning.
• Support technology transfer and validation by preparing URS, FAT, SAT, commissioning, IQ/OQ/PQ, validation, and periodic review documentation.
• Lead technical troubleshooting, deviations, investigations, risk management, change controls, and quality documentation.
• Serve as the technical process owner during regulatory inspections and provide on-call support as required.
• Train and mentor Operations, Engineering, Maintenance, and less experienced Process Engineers on sterile processes and GMP practices.

Requirements

• Demonstrated GMP experience in a sterile or aseptic regulated manufacturing environment is required.
• Hands-on experience with multiple relevant technologies, such as automation and controls, PLCs, HMI, aseptic or controlled environments, sterile fill-finish, lyophilization, sterilization, validation, and computerized systems.
• Proficiency in at least one discipline: automation and controls, aseptic fill-finish equipment, sterile processes and materials, maintenance, or validation.
• Ability to independently lead complex troubleshooting and continuous improvement across multiple processes.
• Ability to coach peers and serve as an escalation point for complex technical issues.
• Visa or work authorization sponsorship is not available.

Nice to have

• Bachelor’s degree in Engineering or a related science.
• 4+ years of relevant sterile or aseptic GMP manufacturing experience across multiple disciplines.
• Project management, Six Sigma, analytical troubleshooting, or LEAN manufacturing experience.

Culture & Benefits

• Full-time role on the night shift with schedules subject to operational needs and possible overtime.
• Work may include evenings, weekends, occasional travel, cleanroom gowning, and exposure to noise, chemicals, and moving machinery.
• Benefits include an annual cash bonus, 401(k) with company match, healthcare, paid vacation and holidays, paid leave, tuition reimbursement, and caregiving support.
• Employees must demonstrate and maintain gown qualification standards.