Process Engineer II (Biomanufacturing)

Location: USA - OH - West Chester; on-site manufacturing role

Salary: $70,000–$96,250 per year

Company

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

What you will do

• Own the technical process for assigned IDAP equipment, maintaining centerlines, critical process parameters, material fit-for-use requirements, and operating procedures.
• Drive continuous improvement through changeover reduction, yield and OEE improvement, maintenance reliability, waste reduction, and asset lifecycle management.
• Lead process validation activities and author or review URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports.
• Troubleshoot equipment and process deviations, lead technical investigations and impact assessments, and work with suppliers to resolve technical issues.
• Develop and implement change controls, risk management activities, SOPs, batch records, and rework procedures.
• Provide engineering and project management support, regulatory inspection support, and technical training for Operations, Engineering, and Maintenance.

Requirements

• Prior GMP or regulated manufacturing experience or exposure is required.
• Training or hands-on experience with one or more relevant technologies, such as mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, computerized systems, vision systems, aseptic or controlled environments, packaging equipment, process validation, cleaning validation, or change control.
• Baseline proficiency in automation and controls, aseptic or packaging equipment, process and materials, maintenance, or validation.
• Ability to work with limited supervision and exercise independent judgment.
• A bachelor's degree in engineering or a related science and 2+ years of GMP or regulated pharmaceutical manufacturing experience are preferred.
• Work authorization or visa sponsorship is not available for this position.

Nice to have

• Project management and process-improvement experience.
• Six Sigma or Lean experience.
• Expertise in automation and controls, aseptic or packaging equipment, process and materials, maintenance, or validation.

Culture & Benefits

• Eight-hour Monday–Friday schedule, with possible overtime, evenings, or weekends based on operational needs.
• Occasional travel and work around chemicals, noise, moving machinery, heights, and personal protective equipment may be required.
• Annual cash bonus program and 401(k) with company match.
• Medical, dental, vision, life, disability, family-building, caregiving, and paid-leave benefits.
• Tuition reimbursement and support for professional development.