Sr. Technician, Shared Services Operations - 2nd Shift (Onsite)
Merck
Senior Technician, Operations (FLEx-Sterile team) β Rahway, NJ (100% on-site). Responsibilities include hands-on GMP processing for sterile dosage form development and clinical manufacturing/supply: equipment assembly/disassembly; sterile processing; inventory management; open aseptic formulation in a Grade A isolator and closed formulation in Grade C; manual visual inspection of filled units; and cross-training (e.g., filling). Adhere to GMP, complete electronic GMP documentation, participate in continuous improvement, and support commissioning/qualification/demonstration of new equipment. Collaborate with formulators, engineers, Quality, Safety, and Facilities.
Key Responsibilities:
- Read drawings and assemble sterile equipment
- Operate/maintain cleaning & sterilization equipment (parts washers, dry heat ovens, autoclaves)
- Receive/inspect/store sterile supplies and manage inventory
- Perform sterile formulation per protocols/batch records; operate isolators/Grade A aseptic work
- Perform visual inspections; manage large unit quantities
- Maintain accurate records (ingredient quantities, equipment, environmental conditions)
- Follow GMP/SOPs; identify/escalate deviations; redline SOPs
- Adapt to batch/procedure and schedule changes; communicate risk
- Gown and work in Grade C aseptic behaviors
- Maintain electronic logs (PAS-X preferred); assist training; support investigations and CAPAs
Education/Experience (minimum):
- HS Diploma/GED + 5 years pharma manufacturing/processing; OR Associate in science/engineering + 3 years; OR Bachelor in Engineering Technology/related.
Required Skills:
- Relevant GMP pharmaceutical experience; strong written/verbal communication
- Computer proficiency (MS Office; Equipment HMI; MODA; PAS-X; SAP; calibration/maintenance databases)
- Good eyesight; lift 50 lbs; gowning incl. respirators; flexible overtime
Preferred Skills:
- GDP familiarity; experience with isolators/aseptic filling/sterile manufacturing/ERP (SAP); MES automation; troubleshooting; process improvement.
Application instructions: Apply to the role via the posting (current employees/contingent workers: βapply HEREβ).