Process Engineer II (MSAT) - Dayshift (Biomanufacturing)

Location: Blue Ash, Ohio, United States; onsite pharmaceutical manufacturing role

Salary: $70,000–$96,250 per year

Company

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

What you will do

• Execute technical aspects of product and process technology transfers through successful completion of process performance qualification.
• Design, execute, and document engineering studies, equipment evaluations, process validation activities, and commissioning and qualification work.
• Lead continuous improvement initiatives focused on changeover reduction, yield, OEE, maintenance reliability, and waste reduction.
• Manage change controls, deviations, technical investigations, risk assessments, root cause analysis, and process troubleshooting.
• Author and review SOPs, batch records, rework procedures, validation protocols, reports, and other technical documentation.
• Collaborate with Manufacturing, Facilities, Validation, Quality, Regulatory, Supply Chain, Operations, PMO, engineers, and external suppliers.

Requirements

• Training or experience with mechanics, hydraulics, pneumatics, vacuum technology, electronics, PLCs, HMI, computerized systems, vision systems, refrigeration, unit operations, formulation, packaging, and validation.
• Ability to support manufacturing through data analysis, deviation investigations, and root cause analysis.
• Ability to develop proficiency in automation and controls, packaging equipment, process and materials, maintenance, and validation.
• Strong attention to detail, problem-solving, communication, and collaboration skills.
• Bachelor’s degree in engineering or a related science is preferred.
• Experience in GMP or regulated production environments, project management, Six Sigma, or LEAN manufacturing is preferred.

Culture & Benefits

• Full-time schedule of 8 hours, Monday through Friday, with on-call support as required.
• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, and vision coverage, life and disability insurance, and family-building benefits.
• Paid vacation, holidays, and other paid leave.
• Tuition reimbursement and caregiving support.
• Visa and work authorization sponsorship are not available.