Candidate will be performing manufacturing operations on a lab scale process.
Essential Job Functions:
1. Author production documentation, as required
2. System and equipment suitability checks (compressed air systems, balances, pipettes, mechanical test systems)
3. Review manufacturing batch records upon completion
4. Execute commissioning tasks such as IQ/OQ/PQ
5. Execute preventive maintenance tasks on equipment as assigned.
6. Update Calibration and Equipment Databases with completed PMs and calibrations
7. Update sample management system
8. Chart trace archiving
9. Review particle counts
Adherence to written protocols a must.
Experience in aseptic processing (cleanroom operations) preferred.
>1 year GMP experience.