Filling Set-up Sr. Technician, Operations - Onsite
Merck
Senior Technician, Operations (1st shift 07:30AMβ4:00PM) β R&D Operations roles in Rahway, NJ (FLEx-Sterile team), specifically in Filling.
Key Responsibilities:
- Hands-on troubleshooting and adjustment of process/production equipment for safe, compliant, reliable manufacturing in a cGMP environment.
- Partner with Production, Quality, EHS, and Engineering to drive continuous improvement.
- Operate high-speed automated systems; understand mechanical/digital interfaces, PLC interfaces, and multi-screen HMIs.
- Perform robotic positioning (remote pendant) and work with vision systems.
- Aseptic Processing: Perform sterile filling per GMP/SOPs; perform aseptic interventions within a Grade A isolator.
- Isolator and filler operation; maintain/operate large complex isolators safely.
- Set up/change over/test runs equipment; make mechanical/electrical adjustments.
- Conduct routine microbial/particulate sampling for environmental monitoring.
- Maintain electronic records; follow batch records/protocols; report recurring issues/trends.
- Work in Grade C cleanroom conditions with aseptic behaviors.
- Assist training; identify/escalate issues and support investigations/CAPA.
- Overtime expected for manufacturing support processes.
Education/Qualifications:
- High School Diploma/GED+ or A.A.S. in Applied Science/equivalent or vocational certificate/equivalent military course work.
- Preferred: Trade/technical diploma or A.A.S. in Mechanical/Electrical/Mechatronics/Instrumentation (or related).
Required Experience/Skills:
- 2+ years as a technician in manufacturing/military/aviation/industrial settings, including setup, changeover, assembly/disassembly, operation, and modifications of complex high-speed equipment.
- Strong written/verbal communication; proficient with Microsoft Office; Equipment HMI use; SAP; calibration/maintenance database systems.
- Ability to lift 50 lbs; bend/stoop/squat/crawl/twist/climb ladders; wear cleanroom gowning including respirators.
Preferred Experience/Skills:
- cGMP-regulated pharmaceutical/biotech experience.
- Automotive/aerospace experience.
- Experience with isolators/containment technology, automated aseptic filling, sterile manufacturing, visual inspection in glass vials, SAP/ERP, MES; demonstrated troubleshooting.
Benefits (if eligible): Annual bonus and long-term incentive (if applicable). Comprehensive benefits including medical/dental/vision, 401(k), paid holidays/vacation, compassionate and sick days.