Filling Set-up Sr. Technician, Operations - Onsite

Senior Technician, Operations Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms. This position supports development and clinical manufacturing and supply as part of the FLEx‑Sterile team, specifically in Filling. Responsibilities include hands‑on processing activities that include sterile filling, lyophilization, and capping. Tasks include line set‑up, executing machinability runs, and performing simple adjustments to ensure GMP processing runs smoothly. The individual will partner with and support formulation development colleagues, providing feedback on product and process development. 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 and maximize reliability of manufacturing operations. Comfortable with complex, high‑speed automated systems with mechanical and digital interfaces. Familiar with robotic positioning and manual placement using remote pendant to position axis. Have experience with vision systems. Experience with PLC interfaces and multi‑screen HMIs; experience in automation‑heavy environments. Aseptic processing: Perform sterile filling operations in compliance with GMP and SOPs; perform aseptic interventions within a Grade A isolator. Isolator and filler operation: 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 in electronic system; knowledge of PAS‑X is preferable. Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations; report recurring issues or trends to management. Gown and work in Grade C cleanroom conditions, maintaining good aseptic cleanroom behaviors. Communicate clearly with team and work closely 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 escalate issues, perform basic troubleshooting, and capture learnings to improve systems and processes. Support investigations and implementation of corrective/preventative actions. Overtime is expected for manufacturing support processes. Education Minimum Requirements High School Diploma/GED or higher. Successful completion of an associate degree in Applied Science (A.A.S.) or equivalent, or vocational certificate in lieu of the degree. Preferred: Trade certificate, technical diploma, or Associate of Applied Science in Mechanical Technology, Electrical Technology, Mechatronics, Instrumentation, or related field. Required Experience And Skills 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 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, calibration/maintenance database systems. Willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators. Demonstrated ability to work and communicate 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 industries. Experience with highly 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’s Degree in science or related field. BioWork Certificate (working in an FDA or similar regulated industry). Experience with automated systems (MES, SAP or similar). Demonstrated troubleshooting/problem‑solving skills. Work Location and Shift Rahway, NJ. 100% on‑site. 1st shift: 07:30 AM – 04:00 PM. Salary Range $68,000 – $107,000. Salary based on education, experience, and other factors such as location. Equal Opportunity Employer We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment. We prohibit discrimination based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. Requisition ID: R404920 #J-18808-Ljbffr Merck