Sr Operator - Third Shift
Core
Senior Operator supporting daily manufacturing, filling, packaging, and production activities in a regulated cleanroom environment.
Role type
Senior IC manufacturing operator
Builds
Pharmaceutical/biotech products and packaging
Domain
Life Sciences / Manufacturing
Required skills
GMP/cGMP compliance, SOP execution, equipment operation, troubleshooting, documentation accuracy, training others, inventory management, changeover procedures
Preferred skills
cGMP/GMP-regulated environment experience, cleanroom experience, lead operator experience, equipment setup and cleaning
Technologies
Manufacturing equipment, packaging machinery, production records
Responsibilities
Perform and coordinate manufacturing, filling, packaging, labeling, inspection, and other production activities according to approved procedures. Set up, operate, monitor, clean, and perform routine adjustments to manufacturing and production equipment. Serve as a subject matter resource for Operators I and II by providing guidance, coaching, and hands-on training. Verify that production activities are performed according to approved SOPs, Work Instructions, Batch Records, and applicable cGMP requirements. Perform and document required in-process checks, inspections, measurements, and verifications. Monitor equipment and production processes to identify abnormalities, quality concerns, or potential equipment issues. Perform first-level troubleshooting and make approved equipment adjustments. Ensure proper material identification, handling, reconciliation, staging, and movement. Maintain accurate inventory and production records. Perform line clearance, equipment clearance, cleaning, sanitation, and changeover activities. Support startup, shutdown, and product changeover activities. Ensure all required safety procedures and PPE requirements are followed. Participate in continuous improvement initiatives focused on safety, quality, productivity, waste reduction, and operational efficiency. Communicate production status, equipment issues, quality concerns, and outstanding actions during shift handoffs and daily production meetings.
Seniority
Senior, hands-on IC
