Process Engineer III (MSAT)

Location: West Chester, Ohio, United States; work is performed in office and cGMP manufacturing environments with cleanroom, gowning, PPE, and safety requirements. Monday–Friday dayshift, with possible on-call support and occasional work outside standard business hours.

Salary: $80,000–$121,250 per year, plus an annual cash bonus program.

Company

hirify.global is a technology-focused biomanufacturing company developing high-tech, end-to-end manufacturing solutions for pharmaceutical production.

What you will do

• Own assigned technology transfers from feasibility through PPQ completion and commercial introduction.
• Lead continuous improvement initiatives focused on changeover reduction, yield, OEE, maintenance reliability, and waste reduction using DMAIC and root-cause analysis.
• Author and independently approve URS, FAT, SAT, commissioning, IQ/OQ/PQ, validation, change control, SOP, and batch record documentation.
• Manage engineering projects, capital planning input, equipment lifecycle activities, obsolescence planning, and manufacturing or facility improvement initiatives.
• Lead risk assessments, deviations, CAPAs, technical investigations, troubleshooting, and validation reviews across assigned processes.
• Coach Process Engineer I and II staff, deliver technical training, and manage relationships with equipment and material suppliers.

Requirements

• GMP experience in a regulated pharmaceutical manufacturing environment and the ability to independently apply controlled procedures and quality standards.
• Experience in one or more MSAT areas, such as PLCs, computerized systems, vision systems, aseptic or controlled environments, formulation, aseptic filling, assembly, packaging, process validation, technology transfer, or change control.
• Proficiency in more than one relevant discipline, including automation and controls, formulation, aseptic filling, packaging equipment, automated visual inspection, technology transfer, or validation.
• Ability to independently lead technical troubleshooting and continuous improvement efforts and mentor peers.
• Bachelor’s degree in engineering or a related science and 4+ years of GMP, regulated pharmaceutical manufacturing, or MSAT experience are preferred.
• Sponsorship or support for work authorization, including visas, is not available.

Nice to have

• Project management experience leading technology transfer workstreams through PPQ completion.
• Experience with Six Sigma, analytical troubleshooting, or Lean manufacturing.

Culture & Benefits

• Full-time employment with healthcare, dental, and vision coverage.
• 401(k) plan with a generous company match.
• Paid vacation, paid holidays, and other paid leaves of absence.
• Family-building benefits, life and disability insurance, caregiving support, and tuition reimbursement.
• Work includes regular access to manufacturing-floor equipment and may require lifting up to 20 pounds.