Night-Shift Drug Product Manufacturing Associate

tsu.edu; Norwood (MA); Sur place; USD 100 289 000 - 108 886 000; Plein temps

Résumé du poste

tsu.edu in Norwood, MA is seeking a Manufacturing Associate II for Drug Product Operations. You will execute cGMP manufacturing activities, including preparation, sterilization, aseptic filling, and visual inspection, ensuring compliant documentation and reliable operations.

This 6+ month contract requires night shifts (6 PM–6 AM) with weekend coverage and collaboration across functions to support material readiness, batch records, and SAP/MES workflow.

Qualifications

• 2+ years of experience in cGMP manufacturing or related regulated environment.
• Experience with aseptic manufacturing and visual inspection.
• Ability to work 12-hour shifts, including nights, weekends, and overtime as needed.

Responsabilités

• Perform component preparation, sterilization, formulation, sterile filtration, aseptic filling, and visual inspection per SOPs and cGMP.
• Complete equipment checks, line clearances, material staging, and in-process checks.
• Monitor alarms, document impact assessments, and perform batch record review.
• Maintain GMP documentation and support cross-functional teams.
• Support material readiness, inventory, SAP transactions, and deviations handling.
• Provide coverage for 12-hour shifts, including weekends and holidays.

Connaissances

cGMP manufacturing

Aseptic processing

SOP adherence

Batch record review

MES/eBR familiarity

SAP experience

Teamwork and communication

Formation

High school diploma or GED

Associate's or Bachelor's degree in a scientific or technical field preferred

Outils

MES/eBR

SAP

Description du poste

tsu.edu in Norwood, MA is seeking a Manufacturing Associate II for Drug Product Operations. You will execute cGMP manufacturing activities, including preparation, sterilization, aseptic filling, and visual inspection, ensuring compliant documentation and reliable operations.

This 6+ month contract requires night shifts (6 PM–6 AM) with weekend coverage and collaboration across functions to support material readiness, batch records, and SAP/MES workflow.