Associate Manufacturing - Swing Shift Midnight

Role Summary

Associate Manufacturing (Swing Shift) at Amgen Thousand Oaks (ATO). This role supports on-floor manufacturing of cGMP drug substance in manufacturing services and upstream areas under general direction, following cGMP practices. Swing shift hours are 1:00 p.m. to midnight, with an initial schedule of 10‑hour shifts Mon–Thu or Tue–Fri.

• Compliance:
  • Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
  • Ensure proper gowning and aseptic techniques are always followed.
• Process/Equipment/Facilities:
  • Perform hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment and the assigned area.
  • Run and monitor critical process tasks per assigned procedures.
  • Perform in-process sampling, operate analytical equipment, and complete process documentation (EBRs).
  • Complete washroom activities: cleaning equipment, small to large scale, used in production activities.
  • Identify and raise issues and concerns regarding daily routine functions related to process and tasks; collaborate with the team on potential solutions.
  • Perform documentation for assigned functions (e.g., equipment logs, EBRs).
  • Collaborate as part of a cross-functional team (QA/QC, F&E, PD, Regulatory, etc.) in completing production activities.

• Required:
  
  Bachelor's degree; or Associate's degree and 6 months of biotech or pharmaceutical manufacturing, process development or quality experience; or High School diploma/GED and 2 years of biotech or pharmaceutical manufacturing, process development or quality experience.
• Preferred:
  Experience in a regulated industry such as biotechnology or pharmaceutical;
  Basic understanding and process experience in a cGMP manufacturing facility;
  Excellent verbal and written communication;
  Proficient Microsoft Office skills, and knowledge of other electronic systems such as E /MES, Delta V, and Electronic Quality Systems;
  Demonstrated desire and drive to learn and grow understanding of operations and processes.