Sr. Manufacturing Associate I, Label & Packaging
Core
Hands-on operator executing cGMP labeling and packaging operations for parenteral drug products (vials, prefilled syringes), ensuring accuracy, compliance, and line readiness.
Role type
Senior Manufacturing Associate (Label & Packaging)
Builds
Parenteral drug product presentations (vials, prefilled syringes)
Domain
Biopharma / mRNA
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, line setup and changeover, label control and reconciliation, in-process inspection, batch record documentation, equipment troubleshooting, peer coaching, deviation management, gowning and safety protocols
Preferred skills
Experience with electronic manufacturing/labeling systems, knowledge of ALCOA+ principles, packaging batch record management, shift-level problem solving
Technologies
MES, eBR, labeling systems
Responsibilities
Execute line setup, operation, and changeover for labeling and packaging processes; perform and verify line clearances and equipment readiness; conduct label control activities including issuance, use, return, and reconciliation; complete accurate contemporaneous documentation (logbooks, batch records); identify, contain, and escalate deviations and equipment issues; train and coach associates on proper techniques and cGMP behaviors; support shift-level investigations and CAPAs; maintain compliance with safety, gowning, and housekeeping standards.
Seniority
Senior, hands-on IC
