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

Job Title: POCS – Rahway:
Technician, Operations (FLEx Sterile Filling Set-up Technician)

Location:

Rahway, NJ – 100% on-site. Shift: 2nd shift (15:30 to 00:00). Two openings.

Pharmaceutical Operations and Clinical Supply seeks highly motivated individuals for R&D Operations roles in the Rahway FLEx Center to support drug product development and GMP clinical supply of sterile dosage forms. The role supports development, clinical manufacturing, and supply as part of the FLEx-Sterile team, specifically in Filling.

• 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.
• Operate and maintain large complex isolators; perform sterile filling operations in compliance with GMP and SOPs, including aseptic interventions within a Grade A Isolator.
• Set up, change over, and run equipment for various container sizes; make mechanical and electrical adjustments for correct operation.
• Conduct routine microbial and particulate sampling for environmental monitoring.
• Maintain accurate records of inspection results and findings in an electronic system (PAS‑X preferred).
• Follow batch records, protocols, and quality standards; report recurring issues or trends to management.
• Gown and work in Grade C cleanroom conditions; maintain aseptic cleanroom behaviors.
• Communicate clearly with team members and partner groups, ensuring on‑time delivery.
• Assist in training new staff on sterile supply procedures and protocols.
• 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.

• High School Diploma/GED or higher.
• Successful completion of an associate degree in Applied Science (A.A.S.) or equivalent program, or vocational certificate.
• Preferred:
  Trade certificate, technical diploma, or associate degree in Mechanical Technology, Electrical Technology, Mechatronics, Instrumentation, or related field.

• Minimum of 2 years experience as a technician in manufacturing, military, automotive, aviation, or industrial facility, including setup, changeover, assembly, disassembly, operation, and modification of complex high‑speed equipment.
• Demonstrated written and verbal communication skills.
• Proficiency with computer systems and applications:
  Microsoft Office, equipment HMI, SAP, calibration/maintenance database systems.
• Ability to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don cleanroom protective gowning with respirators.
• Team‑work and independent work skills.
• Flexibility to work overtime, especially during shutdowns or emergency repairs.

• Experience in regulated pharmaceutical/biotech manufacturing under cGMP.
• Experience in automotive or aerospace.
• Experience with complex equipment, isolators, containment technology, aseptic filling, sterile manufacturing, visual inspection of glass vials, SAP or other ERP systems.
• Associate’s degree in science or related field.
• Bio Work Certificate or equivalent.
• Experience with automated systems (MES, SAP).
• Strong troubleshooting and problem‑solving skills.

$68,000 – $107,000 annually. Salary within range is determined by education, qualifications, experience, location, mandatory mandates, and business needs. Eligible for annual bonus and long‑term incentive if applicable.

Comprehensive package including medical, dental, vision, and other insurance; retirement benefits (401(k)); paid holidays, vacation, compassionate and sick days.

Employee status:
Regular. Relocation:
Domestic. Visa sponsorship:
No. Travel: 10%. Flexible work arrangements:
Not applicable. Shift: 2nd – Evening. Valid driving license:
No. Hazardous materials: n/a.

We are an Equal Employment Opportunity Employer. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. We encourage applicants from diverse backgrounds and do not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability. For more information about U.S. Equal Opportunity laws, visit the EEOC website.