Manufacturing Associate II, Drug Product Operations - Night Shift

Work in a night shift cleanroom environment supporting cGMP drug product manufacturing at an 100% onsite facility in Norwood, MA. This Manufacturing Associate II role focuses on executing and documenting critical sterile drug product operations, including hands-on manufacturing work and detailed batch record review.

Schedule: 6 PM to 6 AM (12-hour shifts), with coverage that may include weekends, holidays, and overtime as needed. The work environment is smoke-free, alcohol-free, and drug-free.

Pay: $35.00 to $37.00 per hour, plus a 25% shift differential.

What you’ll do

• Perform component preparation, sterilization, formulation, sterile filtration, aseptic filling, and visual inspection in accordance with SOPs and cGMP requirements.
• Execute component preparation steps such as washing, sterilization, staging, and transferring components and equipment.
• Complete equipment checks, line clearances, material staging, in-process checks, and routine cleaning activities.
• Maintain accurate and contemporaneous documentation in MES/eBR, logbooks, and other GMP systems.
• Review batch records to find and resolve documentation errors or discrepancies prior to Quality review.
• Monitor equipment and process alarms, escalate issues, and document required impact assessments.
• Identify and escalate deviations, equipment issues, and process concerns; support troubleshooting and root-cause investigations.
• Support material readiness, inventory activities, material transfers, and applicable SAP transactions.
• Maintain required cGMP, aseptic, safety, gowning, training, and qualification standards.
• Support peer training and continuous improvement initiatives.
• Collaborate with cross-functional teams and provide reliable coverage for assigned 12-hour shifts.

What you bring

• High School Diploma / GED
• 2+ years in cGMP manufacturing, pharmaceutical operations, or a related regulated environment (preferred)
• Preferred experience in aseptic manufacturing and one or more of: component preparation, formulation, filling, visual inspection, or similar manufacturing operations
• Strong attention to detail, including the ability to follow SOPs and complete GMP documentation and batch record reviews
• Basic computer skills; familiarity with MES/eBR and SAP or similar manufacturing software systems (preferred)
• Ability to work in classified cleanroom environments while following strict gowning and aseptic practices
• Ability to work assigned 12-hour shifts, including nights, weekends, holidays, and overtime as required

Tools and systems

• MES/eBR
• SAP
• eBR
• Logbooks

Benefits

• Medical insurance
• Prescription insurance
• Dental insurance
• Vision insurance
• AD&D insurance
• Life insurance offerings
• Short-term disability
• 401K plan (eligibility-based)