Purpose Statement
Performs functions associated with cGMP manufacturing operations within the biologics production facility including working with engineers in setup and calibration tasks as well as performing rework and quality testing related to the production of parts components and final materials.
Uses sophisticated programs (such as LIMS SAP automated control systems etc.) to collect and evaluate operating data which can be used to conduct online adjustments to products instruments or equipment.
Support and lead operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.
Major Responsibilities:
- To perform functions associated with cGMP manufacturing operations within the biologics production facility including working with engineers in setup and calibration tasks as well as performing rework and quality testing related to the production of parts components and final materials
- Use sophisticated programs (such as LIMS SAP automated control systems etc.) to collect and evaluate operating data which can be used to conduct online adjustments to products instruments or equipment and determine and may assist in developing methods and procedures to control or modify the manufacturing process
- Responsible for Cell culture (from vial thaw to production scale) Buffer/ media preparation column chromatography tangential flow filtration and sampling of in process and raw materials.
- Assigns tasks within the shift team to other biotechnologists
- Assists Supervisor in planning and leading area activities to ensure adherence to schedule
- Is involved in regulatory/internal audits and inspections
- Is involved in crossfunctional meetings
- Initiates Demand Work Order
- Reviews executed batch records and worksheets
- Drives the resolution of anomalous processing events
- Sets a positive team environment and inculcates a nurturing AbbVie culture
- Acting Supervisor when Supervisor is not available
Qualifications :
- Bachelor Degree (with at least 5 years of experience working in Biologics Production facility or equivalent).
- Experience should include 3 years of area/stream specific experience.
- As a highly skilled specialist contributes to the development of concepts and techniques.
- Completes complex tasks in creative and effective ways.
- Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues.
- Makes recommendations for new procedures.
- Acts independently to determine methods and procedures on new assignments.
- Assists Supervisor in planning and leading area activities.
- Shift work is required.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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Remote Work :
No
Employment Type :
Fulltime