Purpose:

Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components, and final materials.
Completes batch documentation accurately and thoroughly, while adhering to the required quality and safety standards, and in a productive, cost-effective manner.
Supports operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.

Major Responsibilities:

Operations and Technical

Adhere to cGMP and safety requirements
Executes manufacturing operations to perform operations including but not limited to equipment cleaning and set up as well as stream specific operations like:
- Upstream: Vial Thaw, Inoculation, Cell Culture and Recovery
- Downstream: Chromatography, Filtration, Ultrafiltration, Final Filling
- Central Service: Buffer/ Media Preparation, Autoclave, Glasswash and cleaning processes, Sampling of raw materials.
Carry out daily tasks as assigned by Lead Biotechnologist or Manufacturing Supervisor
Accurately completing documentation on time, accurately and legibly.
Maintains inventory levels to minimize distress
Ensures training is complete and current.
Responsible for overall plant upkeep during the shift.
Reports any anomalous processing events to Lead Biotechnologist or Manufacturing Supervisor timely.

Safety

Adhere to and support all EHS & E standards, procedures, and policies.

Quality

Accurately completes documentation on time, accurately and legibly
Reviews documentation for the completeness and accuracy.
Ensures that all batch related document errors are resolved in a timely manner
Support in preparation for regulatory audits and inspections

Schedule

Adheres to production schedule
Escalates to Lead Biotechnologist or Manufacturing Supervisor in events of unplanned downtimes.

Education

Degree or higher in Sciences, Engineering, or equivalent, with 3–5 years of relevant work experience in the biotechnology or pharmaceutical industry, is preferred.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

Good working knowledge of cGMP and regulatory requirements related to Manufacturing is preferred
Experience with SAP, LIMS, MES systems preferred
Possess problem-solving and troubleshooting skills.
Highly motivated and independent.
Works and communicates with others in a professional and effective manner, within a team-oriented environment.
Rotational shift work is required
Higher job level commensurate with experience

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