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 10โhour shifts MonโThu or TueโFri.
Responsibilities
- 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.
Qualifications
- 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 EBR/MES, Delta V, and Electronic Quality Systems; Demonstrated desire and drive to learn and grow understanding of operations and processes.