Filling Set-up Sr. Technician, Operations - Onsite

Senior Technician, Operations This is a 1st shift position (07:30 AM to 4:00 PM) located in Rahway, NJ at the Formulation, Laboratory, and Experimentation (FLEx) Center, supporting drug product development and GMP clinical supply of sterile dosage forms. The role works in the FLEx‑Sterile team, specifically in Filling. The position is responsible for hands‑on processing activities that include sterile filling, lyophilization, and capping. Specific tasks include filling line set‑up, executing machinability runs, and performing simple adjustments to ensure smooth GMP processing. The role also supports formulation development colleagues by providing feedback on product and process development. Candidates must adhere to GMP procedures, maintain meticulous GMP documentation, demonstrate proficiency with electronic systems, and participate in continuous improvement projects. They may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates collaborate closely with formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline. Key Responsibilities Provide hands‑on troubleshooting and adjustment for process and production equipment to ensure safe, compliant and reliable manufacturing operations in a cGMP‑regulated environment. Work closely with Production, Quality, EHS and Engineering to drive continuous improvement to maximize reliability of manufacturing operations. Operate with complex, high‑speed automated systems with mechanical and digital interfaces. Familiar with robotic positioning, using a remote pendant to position axes. Experience with vision systems. Experience with PLC interfaces and multi‑screen HMIs; familiarity with automation‑heavy environments. Aseptic Processing Perform sterile filling operations in compliance with GMP and SOPs, and perform aseptic interventions within a Grade A Isolator. Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols. Set up, change over, and test runs equipment for various size containers, stoppers, and caps as required; make mechanical and electrical adjustments necessary for correct operation. Conduct routine microbial and particulate sampling for environmental monitoring. Maintain accurate records of inspection results and findings in an electronic system; knowledge of PAS‑X is preferable. Follow established inspection batch records, protocols and quality standards; report recurring issues or trends to management. Gown and work in Grade C cleanroom conditions, maintaining good aseptic cleanroom behavior. Communicate clearly with the team and coordinate with other teams to ensure on‑time delivery. Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards. Identify and elevate issues, perform basic troubleshooting, and capture lessons to improve systems and processes; attend safety, quality, and process improvement initiatives. Support investigations and implementation of corrective/preventative actions. Overtime is expected for manufacturing support processes. Education Minimum Requirements High School Diploma/GED or higher. Completed an associate’s degree in Applied Science (A.A.S.) or an equivalent associate degree program or vocational certificate in lieu of the degree program or equivalent military coursework. Preferred: Trade certificate, technical diploma, or Associate of Applied Science (A.A.S.) in Mechanical Technology, Electrical Technology, Mechatronics, Instrumentation, or a related field. Required Experience and Skills Minimum of 2 years experience as a technician in manufacturing, military, automotive, aviation, or industrial facility, including set‑up, changeover, assembly, disassembly, operation, and modification of complex, high‑speed equipment. Demonstrated written and verbal communication skills. Proficiency in computer systems and applications including Microsoft Office (Word, Excel, Outlook), Equipment HMI use, SAP, and calibration/maintenance database systems. Willingness and ability to lift 50 lbs and perform physical tasks such as bending, stooping, squatting, crawling, twisting, climbing ladders, and donning cleanroom protective gowning including respirators. Ability to work independently and as part of a team. Flexibility to work overtime, especially during shutdowns or emergency repairs. Preferred Experience and Skills Experience in regulated manufacturing (pharmaceutical/biotech) under cGMP. Experience in automotive or aerospace manufacturing. Experience with complex, state‑of‑the‑art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, visual inspection of product in glass vials, SAP or other ERP systems. Associate degree in science or a related field. BioWork Certificate (working in an FDA or similar regulated industry). Experience with automated systems (MES, SAP, or similar). Demonstrated troubleshooting and problem‑solving skills. Benefits Annual bonus and long‑term incentive, if applicable. Medical, dental, vision, and other insurance benefits for employee and family. Retirement benefits, including 401(k). Paid holidays, vacation, compassionate, and sick days. The salary range for this role is $68,000 - $107,000. This range reflects factors such as education, qualifications, certifications, experience, skills, geographic location, and business needs. Equal Employment Opportunity 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. This position is 1st‑day shift, 100% on‑site in Rahway, NJ, with a travel requirement of 10%. #J-18808-Ljbffr