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Manufacturing Services Supervisor
3 weeks ago
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
This Supervisor role leads and facilitates the operations of the Manufacturing Services team in line with all safety, regulatory and operational requirements. They assure the long-term effectiveness of the team: deliver high levels of customer service, ensure quality of product and services, comply with all regulatory requirements, achieve desired financial performance including cost reductions, and build an inclusive culture of high performance for the team.
- Oversee equipment maintenance, calibration, facility services, and production support which includes, but not limited to manufacturing, QC Lab, and R&D work areas. Includes equipment and site modifications, equipment installations, clean room mechanical operation, support production, splitter blade grinding, and removal of medical wastes.
- Ensure all maintenance, calibration, and production support events and procedures are compliant with Abbvie procedures and regulatory standards (FDA/ISO).
- Support root cause failure analysis program with Reliability Engineers as needed. Attend weekly downtime meetings with corporate reliability team to address equipment downtime on critical production equipment. Key contributor to all audits, including FDA, ISO, customer, and internal audits.
- Prepare and report on monthly equipment KPIs that feeds into corporate's Maintenance Excellence Program. Ensure production is supported with consumable equipment materials as needed (clean air cylinders/Solujet). Reconcile internal Medical Waste logs with Medical Waste Vendor disposal reports.
- Address department's (Production Support, Mfg Services & Facilities) non-conformance, investigations and CAPA actions. Support corporate and site Maximo team projects and backup to Mfg Services for corporate MEP and Perfect index reports. SME and site administrator for Maximo.
- Provide off-hour support (on-call) to ensure base business needs are met
Qualifications
- Degree, Technical/Science, or equivalent experience (5yrs)
- Minimum 5 years medical device, pharma or biologics preferred
- High proficiency with a wide variety of production equipment, analytical equipment and clean room operations.
- Excellent understanding of GMP and Quality System Operations
- Experience with CMMS, SAP and TrackWise systems preferred
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's 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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