About the Role
- Perform and document daily manufacturing operations according to SOPs in a cGMP environment.
- Operate biologics production equipment (bioreactors, filtration units, chromatography systems, fixed/portable vessels) and execute validation protocols.
- Report to the Manufacturing Supervisor.
- Work a 2-2-3 rotating shift (5:45 PM–6:15 AM).
Responsibilities
- Dispense, label, transfer/stage raw materials and parts.
- Assemble/disassemble, clean, and sterilize components and equipment.
- Maintain equipment/area/cleaning logbooks; perform basic trouble-shooting.
- Document cGMP data (batch records, work orders, equipment logbooks) and execute batch records/validation protocols.
- Manage process parameters in batch record/control systems (with guidance) and assist with manufacturing support.
- Review equipment use logs; perform inventory transactions in SAP; enter data into LIMS.
- Clean/sanitize production equipment.
Qualifications / Skills
- High school diploma or GED.
- GMP experience preferred; cGMP and GDP understanding preferred.
- Associate degree or higher in a scientific discipline preferred.
- Knowledge of non-manufacturing functions (QC/Regulatory/QA/Materials Management) a plus.
- Prior lab equipment experience a plus.
- Basic math (addition/subtraction/division/multiplication, rounding); basic computer skills (MS Office, email, WBT training).
Benefits (eligibility stated)
- Medical/dental/vision, 401(k) match, disability, life insurance, tuition reimbursement, paid time off, holidays, sick time, and vacation (per calendar year/eligibility terms).