Associate Director, Maintenance-Metrology - United States
Directs and manages the work of the Maintenance and Metrology departments supporting 24/7 GMP commercial and clinical operations. Leads by example, instills a culture of safety and delivers results to client groups. The successful candidate will serve as a key member of the ARIMF Management Work Center Team. This will be a highly visible position interacting with a variety of functional groups and Alexion employees at multiple levels
- Lead the teams responsible for maintenance, calibration, troubleshooting and repair on a variety of complex manufacturing equipment and utility systems.
- Serves as subject matter expert for Maintenance and Metrology in the support internal audits and regulatory agency inspections.
- Area owner and subject matter expert for deviations, CAPAs and change controls in the Trackwise system.
- Manages contract service providers; including scheduling, training, coordination and ensuring all work and documentation is performed in accordance with GMP requirements. Also responsible for the issuance of purchase orders and financial tracking of invoices.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Generates and revises Standard Operating Procedures pertinent to maintenance and calibration activities.
- Ensure completion of preventative maintenance and capital improvement activities in accordance with shut down plan. Provide on-call support during project and shutdown activities, as required.
- Establish and maintain working relationships with key facility stakeholders - Quality Assurance, Quality Control, Manufacturing, Technical Services and Engineering teams - to ensure efficient management of ARIMF manufacturing activities.
- Communicate operational status regularly to senior plant management and to corporate management, as required, at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
- Responsible for the development of the reliability based maintenance program and asset replacement strategy.
- Implements metrics and KPI’s to monitor and drive performance of the Maintenance and Metrology teams in direct support of the Integrated Management System.
- Ensuring all work is carried out safely and is in compliance with cGMP’s and Good Engineering Practices (GEP).
- A minimum of 12 years of maintenance, calibration, troubleshooting and repair experience in a cGMP manufacturing environment with at least 8 years in a management role
- Excellent interpersonal, written, and verbal communication skills, with demonstrated ability to effectively present complex technical details of manufacturing processes to senior management, regulatory agency representatives, and external parties
- Prior hands-on experience with CMMS (Infor EAM, Maximo, RAM, etc.)
- Prior experience utilizing Trackwise to manage change controls, CAPAs and deviations
- Ability to manage several teams and/or staff with coaching and career development.
- Ability to present and defend technical aspects of this role during regulatory agency inspections
- Ability to translate and capture the essential details of complex process information into clear, practical, and concise written and oral presentations
- Build high performing, engaged and effective teams through motivation and inspiration.
- Build trust and collaboration by delivering exceptional service
- BS in Engineering/Life Sciences/Management
- Combination of equivalent work experience, military training and education may be considered
Smithfield, RI, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer