Process Engineer II (Relocation Assistance)

Location: USA - OH - Blue Ash; onsite role. Full-time, Monday-Friday, 8-hour schedule, with possible extended hours, evenings, weekends, overtime, on-call support, and occasional travel. Relocation assistance is offered.

Base pay: $70,000-$96,250 per year. Actual pay depends on geographical location, experience, qualifications, skills, and knowledge.

Company

hirify.global is a technology-focused biomanufacturing company building a sustainable network of high-tech, end-to-end manufacturing solutions.

What you will do

• Own the technical processes for assigned IDAP equipment, maintaining centerlines, critical process parameters, material fit for use, and operating procedures.
• Drive continuous improvement through changeover reduction, yield and OEE improvement, maintenance reliability, waste reduction, and asset lifecycle management.
• Lead engineering and project-management activities, including project justification, milestone tracking, capital planning, and user requirements for new equipment.
• Lead process validation, define success criteria, confirm process capability, and maintain the validated state through change.
• Troubleshoot equipment and process deviations, work with equipment and material suppliers, and support technical investigations and impact assessments.
• Author and review URS, FAT, SAT, commissioning, IQ/OQ/PQ protocols and reports, SOPs, batch records, rework procedures, change controls, risk-management documentation, and training materials; support regulatory inspections.

Requirements

• Prior experience or exposure in a GMP or regulated manufacturing environment, with the ability to follow controlled procedures and quality standards.
• Training or hands-on experience in one or more IDAP-relevant technologies, including mechanics, hydraulics, pneumatics, vacuum systems, electronics, PLCs, HMI, computerized systems, vision systems, aseptic or controlled environments, packaging equipment, process or cleaning validation, or change control.
• Baseline proficiency in at least one discipline: automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.
• Ability to work with limited supervision and exercise independent judgment on assigned processes.
• Ability to meet the physical requirements of the role, including lifting or carrying up to 20 lbs, occasional work at heights up to 5 ft, use of personal protective equipment, extended computer use, required visual acuity, and the ability to hear and distinguish sounds used in interpersonal and group conversations.

Nice to have

• Bachelor's degree in Engineering or a related science and 2+ years of experience in a GMP or regulated pharmaceutical manufacturing environment.
• Experience with project management and process-improvement methodologies such as Six Sigma or Lean.
• Expertise in automation/controls, aseptic/packaging equipment, process/materials, maintenance, or validation.

Culture & Benefits

• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, and vision coverage, family-building benefits, life and disability insurance.
• Paid vacation, paid holidays, other paid leave, tuition reimbursement, and caregiving support.
• Work in a regulated, technology-focused biomanufacturing environment with collaboration across Manufacturing, Quality, Maintenance, Engineering, and equipment suppliers.
• Visa or other work-authorization sponsorship and support are not available for this position.