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

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. Positions will support development and clinical manufacturing and supply as part of the FLEx-Sterile team, specifically in Filling.

About the role

This position will be 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 GMP processing runs smoothly. These individuals are expected to partner with and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development.

Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.

Overtime is expected for manufacturing support processes. Positions are based in Rahway, NJ and are 100% on-site.

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 complex, high-speed automated systems with mechanical and digital interfaces.
• Perform robotic positioning, including manual placement utilizing remote pendant to position axis.
• Utilize vision systems and PLC interfaces with multi-screen HMIs in automation-heavy environments.
• Perform aseptic processing and sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• 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 run 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 in an 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 conditions, maintaining good aseptic cleanroom behaviors.
• Communicate clearly with the team and collaborate 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.
• Actively participate in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
• Support investigations and implementation of corrective/preventive actions.

Requirements

• High School Diploma/GED or higher, or successful completion of an associate degree in Applied Science (A.A.S) or an equivalent associate degree program, vocational certificate, or equivalent military coursework.
• Minimum of 2 years of 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.
• 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, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators.
• Demonstrated ability to work and communicate both independently and as part of a team.
• Flexibility to work overtime, especially during shutdowns or emergency repairs.

Qualifications

Preferred:

• Trade certificate, technical diploma, or Associate of Applied Science (A.A.S.) in Mechanical Technology, Electrical Technology, Mechatronics, Instrumentation, or a related field.
• Experience in regulated manufacturing (pharmaceutical/biotech) under cGMP.
• Experience in automotive or aerospace.
• Experience with highly complex and state-of-the-art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, or visual inspection of product in glass vials.
• Associate 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.

Pay

The salary range for this role is $68,000 - $107,000. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

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

Schedule

2nd shift (15:30 to 00:00).

There are 2 positions open for this role.