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 and leads operations & troubleshooting efforts during course of shift work to ensure adherence to schedule and production plan.
- Stands in as Deputy for Manufacturing Supervisor in his/her absence.
Major Responsibilities:
Operations and Technical
- Demonstrates ownership of upstream-specific operation area, including Inoculation, Cell Culture and Recovery
- Plans and executes manufacturing operations using validated programs (such as LIMS, SAP, DeltaV, POMSnet, automated control systems, etc.)
- Completes manufacturing tasks efficiently
- Demonstrates high degree of initiative to resolve issues
- Makes recommendations for and implements new procedures
- Acts independently to determine methods and procedures on new assignments
- Drives projects and innovations to streamline processes and operation steps
- Drives the resolution of anomalous processing events timely
- Initiates Demand Work Order
Safety
- Ensured safe work environment in accordance with regulatory and global/local EHS policies
- Reinforces importance of safety during critical operations and ensure that Positive Interventions and recommendations are regularly highlighted and acted upon.
- Leads safety risks assessments or participates in process hazard analysis as an operations representative (PHA)
Quality
- Responsible for the completeness and accuracy of all records
- Ensures that all batch related document errors are resolved in a timely manner to avoid batch review and release delays
- Communicates all events/issues effectively with relevant stakeholders
- Drive performance to ensure execution is carried out flawlessly to ensure Human Error related events are prevented
- Responsible for overall plant upkeep during the shift and ensuring plant is always in audit ready mode
- Is involved in preparation for regulatory audits and inspections
- Initiates Quality Records (Non-conformance)
Schedule
- Assists supervisor in planning to ensure adequate resources are available to support manufacturing demands per production schedule.
- Assigns tasks within the shift team to biotechnologists
- Provides inputs to supervisor and manufacturing planner in events of unplanned downtimes
- Represents the shift in cross-functional meetings
People and Culture
- Sets a positive team environment and exemplifies the AbbVie Ways We Work behaviors
- Coaches and trains other biotechnologists (100% trainer competency)
- Assists in developing training materials
- Bachelors in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent
- Min 5+ years of relevant work experience in Biologics / Pharmaceutical industry required. Experience should include 3+ years of area / upstream specific experience, including Inoculation, Cell Culture and Recovery
- Experience leading a shift team required
- Highly skilled specialist and strong problem solver who independently tackles complex assignments with initiative, contributing to the development of innovative concepts and techniques
- Demonstrated ability to multi-task and work in a fast-paced environment, takes full ownership of tasks assigned and acts with personal integrity
- Knowledge of complex technical issues and manufacturing experience in a biopharmaceutical / pharmaceutical or similar environment
- Good interpersonal and communication skills required
- Excellent team player, with experience in shift work required
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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