Operations Lead (Shop Floor Supervisor) (Pharmaceutical Manufacturing)

Location: Rahway, New Jersey, United States of America; onsite role at the Rahway facility. Weekly rotation between 1st and 2nd shifts may be required. Travel requirements: 10%.

Salary: $87,300–$137,400 per year, plus annual bonus and long-term incentive eligibility where applicable.

Company

hirify.global develops pharmaceutical products and operates research, development, and GMP manufacturing facilities.

What you will do

• Support the MACS Center from equipment testing and facility startup through full operation.
• Contribute to equipment and facility design, system commissioning and qualification, and startup workstreams.
• Supervise and participate in daily production activities while meeting Safety, GMP Quality, Environmental, and customer requirements.
• Prioritize and assign daily activities for operations staff and coordinate maintenance around processing activities.
• Implement process improvements and ensure facility readiness for active pharmaceutical ingredient processing.
• Collaborate with MACS leadership and cross-functional partners to support facility performance and may support other facilities across the Small Molecule PR&D network.

Requirements

• Bachelor’s degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or a related engineering or scientific discipline plus at least 2 years of relevant experience in a process development lab, pilot plant, manufacturing facility, or operations environment; or a high school diploma plus at least 6 years of relevant experience in a process development lab or pilot plant/manufacturing facility.
• Mechanical aptitude and familiarity with chemical process development and process equipment.
• Experience supervising shop floor personnel in an operations environment.
• Experience with current cGMPs, Good Documentation Practices, and Safety & Environmental regulations.
• Experience operating and maintaining manufacturing-scale, pilot-scale, and/or lab-scale equipment.
• Effective communication, collaboration, conflict resolution, root cause analysis, relationship-building, adaptability, and willingness to learn, contribute, and lead.
• Ability to coordinate maintenance activities around processing activities and work with automation systems such as DeltaV and PLCs.
• Ability to rotate between 1st and 2nd shifts weekly as the facility transitions toward equipment qualification and operations.
• Required skills include competency management, corrective action management, electronic batch records, manpower planning, manufacturing processes, pilot plant operations, process engineering, root cause identification and investigations, and troubleshooting.

Nice to have

• Experience with GMP facility design, equipment startup, and/or qualification.
• Small molecule drug substance and/or biologics process development experience.
• Experience supporting compliance investigations and change management.
• Experience with Process Hazard Analysis and/or Level of Protection Analysis.
• Experience with potent compound processing and containment systems such as isolators.
• Experience with process utility systems for large drug substance pilot plants, including WFI generation and distribution, process chillers, and vacuum systems.
• Experience with quality system notifications, RCA, CAPA, quality change controls, and/or safety MOC.

Culture & Benefits

• Collaborative, learning-focused, and innovation-oriented operations culture.
• Medical, dental, vision, and other insurance benefits for employees and families.
• Retirement benefits including a 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Regular employee status with no relocation and no visa sponsorship.
• Inclusive workplace with equal employment opportunity and accommodation support during the hiring process.