Manufacturing Associate

Manufacturing Associate II, Drug Product Operations Role Overview

The Manufacturing Associate II, Drug Product Operations executes cGMP manufacturing activities, including component preparation, sterilization, material wiping and transfer, formulation, filtration, aseptic filling, and visual inspection.

This role supports equipment and material readiness, performs in-process checks, monitors and responds to alarms, documents impact assessments, and conducts batch record reviews. The Associate ensures accurate GMP documentation and collaborates cross‑functionally to maintain safe, compliant, and reliable manufacturing operations.

$ per hour (plus 5% shift differential)

• Perform component preparation, sterilization, formulation, sterile filtration, aseptic filling, and visual inspection in accordance with SOPs and cGMP requirements.
• Execute component preparation activities, including washing, sterilization, staging, and transfer of components and equipment.
• Complete equipment checks, line clearances, material staging, in‑process checks, and routine cleaning activities.

• Complete accurate and contemporaneous documentation in MES/e , logbooks, and other GMP systems.
• Perform batch record reviews to identify and resolve documentation errors or discrepancies prior to Quality review.
• Identify and elevate deviations, equipment issues, and process concerns; support troubleshooting and root-cause investigations.

• Monitor equipment and process alarms, elevate issues, and document required impact assessments.
• 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 (including weekends, holidays, and overtime as needed).

• Required: High School Diploma / GED
• Preferred: Associate's or Bachelor's degree in a scientific or technical field

• Experience: 2+ years in cGMP manufacturing, pharmaceutical operations, or a related regulated environment (preferred).
• Technical Background: Experience with aseptic manufacturing, component preparation, formulation, filling, visual inspection, or similar manufacturing operations (preferred).
• Compliance & Quality: Strong attention to detail with demonstrated ability to follow SOPs, execute GMP documentation, and perform batch record reviews.
• Systems: Basic computer skills and familiarity with MES/e , SAP, or other manufacturing software systems (preferred).

• Ability to work effectively in classified cleanroom environments, adhering to strict gowning and aseptic practices.
• Strong communication, teamwork, and reliability with a proactive approach to identifying and escalating process, equipment, or alarm issues.
• Capability to work assigned 12‑hour shifts, including nights, weekends, holidays, and overtime as required.

• Onsite Expectation:
  100% Onsite
  . Being physically present is critical to site-based operations, real-time collaboration, strong team connections, direct mentorship, and hands‑on partnership.
• Workplace Culture: This is a smoke‑free, alcohol‑free, and drug‑free work environment.