Associate Specialist, Technical Operations Engineer (On-site) (Biopharmaceutical Manufacturing)

Location: On-site in Rahway, New Jersey, United States; US and Puerto Rico residents only. First-shift, day schedule; 10% travel; no relocation; visa sponsorship is not available.

Base salary: $71,900–$113,200 per year, plus annual bonus and long-term incentive eligibility where applicable.

Company

hirify.global develops pharmaceutical and biopharmaceutical products and operates regulated clinical manufacturing environments.

What you will do

• Own manufacturing equipment trains or technical capability areas within FLEx Non-Sterile clinical manufacturing.
• Maintain equipment readiness and provide on-floor technical support during campaigns, turnovers, changeovers, batch execution, and closeout.
• Coordinate with Production, Process Engineering, Quality, Facilities, Maintenance, Automation, vendors, and project teams to resolve equipment and operational issues.
• Lead or support troubleshooting, deviations, atypical-event investigations, root cause analysis, CAPAs, change controls, and GMP documentation.
• Lead improvement initiatives using operational data, batch reports, alarm history, downtime information, digital manufacturing systems, and visual management.
• Support capital projects through design reviews, risk assessments, FAT/SAT, commissioning, qualification, startup, and operational handover.

Requirements

• B.S. or M.S. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related discipline, with expected graduation no later than December 2026.
• Ability to troubleshoot technical problems, organize actions, and drive issues toward resolution.
• Ability to author and review clear technical documentation and follow controlled procedures.
• Strong planning, prioritization, communication, and cross-functional collaboration skills.
• Ability to work effectively in an on-site manufacturing environment and support changing operational priorities.
• Ability to meet applicable medical screening and physical requirements for the manufacturing area.

Nice to have

• Experience with technical work, manufacturing operations, equipment, or process improvement in laboratory, pilot plant, pharmaceutical, biotechnology, or other regulated environments.
• GMP pharmaceutical or biotechnology manufacturing experience and knowledge of Good Documentation Practices.
• Experience with oral solid dosage or specialty processes, including tablet compression, encapsulation, spray drying, film coating, blending, granulation, powder handling, containment, or device assembly.
• Experience with equipment ownership, maintenance coordination, automation troubleshooting, investigations, CAPAs, change controls, or risk assessments.
• Experience with capital projects, commissioning, qualification, validation, FAT/SAT, or equipment startup.
• Experience with Lean, Six Sigma, structured problem solving, continuous improvement, digital manufacturing systems, or operational data analysis.
• Experience with PAS-X, SAP, PI/historian systems, Power BI, data analytics platforms, or maintenance/calibration systems.

Culture & Benefits

• Regular employment with medical, dental, vision, insurance, retirement, 401(k), paid holidays, vacation, and sick-day benefits.
• Work is performed on-site during the first shift, with cross-shift technical support and 10% travel.
• Inclusive environment that encourages diverse perspectives, respectful challenge, collective problem solving, and knowledge sharing.
• Medical screening and physical requirements apply to work in the manufacturing area.