Filling Set-up Sr. Technician, Operations; 2nd Shift - Onsite

Position Summary

Pharmaceutical Operations and Clinical Supply seeks a Technician, Operations (FLEx Sterile Filling Set‑up Technician) to support drug product development and GMP clinical supply of sterile dosage forms at our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center. The role focuses on sterile filling, lyophilization, and capping, including line set‑up, machinability runs, and equipment adjustments to maintain GMP processing.

• Hands‑on troubleshooting and adjustment of process and production equipment for safe, compliant, and reliable manufacturing in a cGMP‑regulated environment.
• Work closely with Production, Quality, EHS, and Engineering to drive continuous improvement and maximize reliability of manufacturing operations.
• Operate and maintain large, complex isolators, perform set‑ups, change‑overs, and test runs for various container sizes, stoppers, and caps.
• Execute aseptic filling operations in compliance with GMP and SOPs, including interventions within a Grade A Isolator.
• Conduct routine microbial and particulate sampling for environmental monitoring and maintain accurate electronic records (PAS‑X preferred).
• Maintain inspection batch records, protocols, and quality standards; report recurring issues or trends to management.
• Gown and work in Grade C cleanroom conditions, adhering to aseptic cleanroom behaviors.
• Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
• Identify and escalated issues, perform basic troubleshooting, and capture learnings to improve systems and processes.
• Participate in safety, quality, and process improvement initiatives; support investigations and corrective/preventative actions.
• Work overtime as required to support manufacturing processes.

• High School Diploma/GED or higher, or successful completion of an associate’s degree in Applied Science (A.A.S.) or a related program.
• Minimum of 2 years experience as a technician in a manufacturing, military, automotive, aviation, or industrial facility, including set‑up changeover, assembly, disassembly, operation, and modifications of complex, high‑speed equipment.
• Experience in regulated manufacturing (pharmaceutical/biotech) under cGMP strongly preferred.

• Strong attention to detail in GMP documentation and familiarity with electronic systems.
• Proficiency in Microsoft Office (Word, Excel, Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems.
• Mechanical, electrical, and digital interface expertise; knowledge of robotic positioning, vision systems, PLC interfaces, and multi‑screen HMIs.
• Ability to lift 50 lbs and perform physical tasks such as bending, stooping, squatting, crawling, twisting, climbing ladders, and donning cleanroom protective garments including respirators.
• Excellent written and verbal communication skills; ability to work independently and as part of a team.
• Flexibility to work overtime, especially during shutdowns or emergency repairs.

• Knowledge of highly complex and state‑of‑the‑art equipment, isolators, containment technology, aseptic filling machinery, and sterile manufacturing processes.
• Experience with visual inspection of product in glass vials, SAP or other ERP systems, MES, or similar automated systems.
• Bio Work Certificate or equivalent training in FDA or similar regulated industry.
• Mechanical Technology, Electrical Technology, Mechatronics, Instrumentation, or a related technical diploma or associate degree.

Salary range: $68,000 – $107,000, based on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. Eligible for annual bonus and long‑term incentive if applicable.

Comprehensive package including medical, dental, vision, other healthcare and insurance benefits for employee and family, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.

Second shift (15:30 – 00:00). 100% on‑site in Rahway, NJ. Overtime expected for manufacturing support processes.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC and related resources.