Maintenance Technician IV, Lead - Sterile Operations (Night Shift) (Biomanufacturing)

Location: West Chester, Ohio, United States; onsite night shift from 6:00 PM to 6:30 AM on a rotating 12-hour schedule

Salary: $28.50–$46.50 per hour

Company

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

What you will do

• Lead and monitor filling operations, batch setup, execution, technical interventions, equipment operation, and material handling.
• Resolve complex production issues and provide technical support to production and mechanical technicians.
• Perform filter integrity testing, equipment assembly and disassembly, sanitization, cleaning, and support for preventive maintenance.
• Complete advanced batch records and GMP documentation, review records for accuracy, and manage inventory reconciliation in SAP.
• Train team members as a certified on-the-job trainer and participate in 5S, continuous improvement, problem-solving, and daily tier meetings.
• Support investigations, root cause analysis, CAPAs, audits, and regulatory inspections.

Requirements

• Significant experience in pharmaceutical, biotechnology, or cGMP-regulated manufacturing; 4+ years is preferred.
• Advanced knowledge of cGMP requirements, regulatory expectations, quality systems, deviations, CAPAs, audits, and inspections.
• Ability to read, write, speak, and understand English to communicate complex technical information.
• Strong documentation, mathematical, analytical, organizational, and problem-solving skills.
• Experience with investigations, root cause analysis, corrective and preventive actions, and peer training.
• Ability to work onsite in West Chester, Ohio, on the stated night-shift rotation; visa or work-authorization sponsorship is not available.

Nice to have

• High school, vocational school, or equivalent education.
• Lean manufacturing experience.
• Working knowledge of Microsoft applications, SAP, or Veeva Vault.

Culture & Benefits

• Work in controlled and classified cleanroom production areas with aseptic gowning and personal protective equipment.
• Participation in an occupational health program, including possible medical assessment, surveillance, vaccination, and testing.
• Benefits include healthcare, dental and vision coverage, family-building benefits, life and disability insurance, paid vacation, paid holidays, and other paid leave.
• Additional benefits include a 401(k) plan with company match, annual cash bonus opportunity, tuition reimbursement, and caregiving support.