Senior Technician, Filling Operations (2nd Shift) - Onsite

This position is a second shift role with hours of 3:30 PM to 12:00 AM, based in Rahway, NJ, and is 100% on-site.

About the role

Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R&D Operations roles in the 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.

This role involves hands-on processing activities, including room setup, equipment and material preparation, equipment assembly and disassembly, cleaning, and processing raw materials into finished drug product. Individuals will partner with formulation development colleagues to enhance understanding and knowledge capture of processes, providing feedback on product and process development.

These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. 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.

Responsibilities

• Prepares, operates, and cleans equipment and facilities used in clinical development and manufacturing processes.
• Maintains, inventories, and transports required processing equipment, materials, supplies, and products.
• Executes all documentation and clerical functions necessary to maintain Good Manufacturing Practice (GMP) operations, using paper-based and electronic systems.
• Maintains detailed knowledge of process equipment and operations. Troubleshoots equipment/systems to resolve issues and aid in technology and process development, capturing learnings to improve systems and processes.
• Attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
• Supports investigations and implementation of corrective/preventative actions.
• Mentors and trains other team members within the department.

Requirements

• High School Diploma/GED with at least 5 years in pharmaceutical manufacturing or processing, OR
• Associate’s Degree in a Science/Engineering-related field with at least 3 years in pharmaceutical manufacturing, OR
• Bachelor’s Degree in Engineering Technology or a related field.

Skills

• Relevant GMP pharmaceutical experience or equivalent (e.g., chemical, nuclear, military experience).
• 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.

Preferred Skills

• Familiarity with regulatory requirements and Good Documentation Practices (GDP).
• 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.
• Experience with SAP or other ERP systems.
• BioWork Certificate (working in an FDA or similar regulated industry).
• Experience with automated systems (MES, SAP, or similar).
• Demonstrated troubleshooting and problem-solving skills.
• Demonstrated ability to identify and initiate process improvements.

Pay

The salary range for this role is $63,800 - $100,400. An employee’s position within the salary range will be based on 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

We offer a comprehensive package of benefits, including:

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

Schedule

Second shift: 3:30 PM to 12:00 AM.