Filling Set-up Sr. Technician, Operations (2nd Shift) - Onsite
Core
Hands-on setup, operation, and troubleshooting of sterile filling lines, lyophilization, and capping equipment in a cGMP pharmaceutical manufacturing environment.
Role type
Senior IC sterile filling set-up technician
Builds
Sterile dosage forms for drug product development and clinical supply
Domain
Biopharmaceutical manufacturing / Sterile processing
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic processing, Isolator operation, PLC interfaces, HMI operation, Vision systems, Mechanical/electrical adjustments, GMP documentation, Environmental monitoring sampling, Cleanroom gowning
Preferred skills
cGMP regulated manufacturing experience, Automotive or aerospace background, SAP/ERP systems, MES systems, BioWork Certificate
Technologies
PLC, HMI, SAP, PAS-X, MES, Isolators
Responsibilities
Set up, change over, and test runs filling line equipment for various containers; Perform sterile filling operations in compliance with GMP; Operate and maintain large complex isolators; Conduct routine microbial and particulate sampling; Maintain accurate electronic records of inspection results; Support commissioning and qualification of new equipment.
Seniority
Senior, hands-on IC