Job Summary
- Manufacture, inspect, and package Anthrax Vaccine Adsorbed per CGMP guidelines and Standard Operating Procedures.
- Complete training and maintain competence via the manufacturing training program.
- Follow Shared Values while performing day-to-day activities.
Essential Functions / Responsibilities
- Complete qualification blocks; demonstrate competency.
- Execute and document CGMP-compliant procedures; follow clean room behavior and SOPs.
- Maintain facility environmental control (cleaning solution prep; daily/monthly/quarterly/annual cleaning).
- Perform real-time documentation review (BPRs, forms, logs, etc.).
- Stock gowning and consumables using Kanban inventory control.
- Follow lean standard work; participate in continuous improvement; engage in Kanban and 6S.
- Inspect/cull product defects; operate labeling equipment with minimal supervision.
- Ensure traceability/expiration on secondary packaging; confirm component suitability via 100% inspection.
- Package product and reconcile product rejects (100%).
- Complete ambient tracking documentation; use SAP modules for material issuance/step confirmation.
- Prep/operate Building 55: weigh/hydrate media; parts washer sterilization/decontamination; assemble glassware/tanks; COP/CIP and SOP/SIP via DeltaV; prepare/dispense intermediates.
- Upstream: clean/sterilize fermenters; sterilize filters/media; inoculate; monitor turbidity; transfer cultures; adjust pH (2N NaOH); integrity test filters; sterilize filter skid.
- Downstream: add ALOH; sample via LIMS; clean/sterilize harvest tanks and centrifuge; dispense/sterilize ALOH.
Minimum Education/Experience/Skills
- HS Diploma.
- 1β2 years CGMP environment experience.
- Knowledge of CGMP/CFR preferred.
- Personal competencies: self-awareness, integrity, team player, creative, culturally aware.
Benefits / Application
- Comprehensive benefits package (details via company link).
- If selected for an interview, speak with an HR partner about compensation philosophy and available benefits.