Senior Technician, Filling Operations; 2nd Shift - Onsite

Job Description

Note:

This position is a second shift position, with hours of 3:30 PM to 12:00 AM.

Positions are based in Rahway, NJ and 100% on‑site.

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. The position supports development and clinical manufacturing and supply, as part of the FLEx‑Sterile team.

This role will be responsible for hands‑on processing activities that include room setup, equipment and material preparation, equipment assembly and disassembly, cleaning, and processing of raw materials into finished drug product. Team members are expected to partner with formulation development colleagues to further understand and capture process knowledge, providing feedback on product and process development.

Requirements include adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. The role may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate with formulators, engineers, Quality, Safety, and Facilities to drive overall success and performance of the area and clinical pipeline.

• Prepare, operate, and clean equipment and facilities used in clinical development and manufacturing processes.
• Maintain, inventory, and transport required processing equipment, materials, supplies, and products.
• Execute all documentation and clerical functions necessary to maintain good manufacturing practice (GMP) operations, using paper‑based and electronic systems.
• Maintain detailed knowledge of process equipment and operations. Troubleshoot equipment/systems to resolve issues and aid in technology and process development, capturing learnings to improve systems and processes.
• Attend and actively participate in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.
• Support investigations and implementation of corrective/preventative actions.
• Mentor and train other team members within the department.

• High School Diploma/GED, with at least 5 years in pharmaceutical manufacturing or processing.
• OR Associates Degree in Science/Engineering related field with at least 3 years in pharmaceutical manufacturing.
• OR Bachelors Degree in Engineering Technology or related field.

• 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 but not limited to Microsoft Office (Word, Excel, and Outlook), Equipment HMI use, SAP, Calibration/Maintenance Database Systems.
• Must be 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 both independently and as part of a team.

• 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, visual inspection of product in glass vials, SAP or other ERP systems.
• Bio Work Certificate (working in an FDA or similar regulated industry).
• Experience with automated systems (MES, SAP, or similar).
• Demonstrated troubleshooting / problem‑solving skills.
• Demonstrated ability to identify and initiate process improvements.

Shift: 2nd – Evening (3:30 PM to 12:00 AM).

Location:

Rahway, NJ (100% on‑site).
Eligibility: US and Puerto Rico residents only.

$63,800 – $100,400

The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits…