Manufacturing Associate I - OQSIE

Duties

 Executes, with oversight of qualified staff, complex unit operations including but not limited to batching and inoculation of

bioreactors, operation of bioreactors, process monitoring, and harvest operations.

- Executes independently with adequate training fundamental operations:

- CIP/SIP of bioreactors, tanks, and harvest equipment.

- Media preparation and transfer into tanks and disposables.

- Cell inoculation and transfer.

- Daily analytics and maintenance of analytical equipment.

- May be required to support parts cleaning and weigh and dispense operations.

- Performs internal support duties including stocking consumables/materials, updating controlled SOP binders,

appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.

- Documents work according to cGMP and cGDP.

- Adheres to established regulations and follows cGMP established by site.

- Reports abnormalities and deviations in a timely and accurate manner.

- Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.

- Maintains production areas according to predefined standards (5s).

- Maintains own training within compliance and trains other technicians and associates on operations upon completion of

trainer qualification.

- Contributes to Quality activities as investigations and area walk-throughs.

Skills

One (1) or more years of experience in cGMP regulated industry.

- Ability to concentrate on detail oriented work in a complex technical setup with a Quality and Right the first time mindset.

- Strong written and verbal communication skills.

- Ability to work with computer-based systems and ideally experience with process control systems (e.g. Delta V) and

manufacturing execution systems (MES).

- Ability to read and understand SOPs and work instructions and document work in a written format applying cGMP

standards.

Education

- High school degree plus minimum one (1) year work experience in GMP regulated industry

- Associates/Bachelor's degree from an accredited institution or biotechnology vocational training preferred.