Senior Director, Site Engineering
Plant Manager College Park
College Park, Blanchardstown, Dublin
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition, and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in more than 40 countries for the treatment of PNH, and in the United States for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris and is pursuing development of other innovative biotechnology product candidates in early stages of development. Further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
The Senior Director of Site Engineering will lead all aspects of facility maintenance and plant and process engineering for the Alexion College Park site. The Senior Director will serve as a member of the College Park Site Leadership Team and ultimately be accountable for driving reliability, efficiency and compliance across a matrix organization.
This position will build and lead a team, including out-sourced services, responsible for various engineering disciplines that deliver critical services to enable production in a bulk drug substance plant and a packaging plant and support operations in a QC Laboratory and GMP Warehouse. The team will be responsible for Capital Projects, Building Management Services, Plant & Process Engineering, Facility Maintenance Planning & Metrology, Plant & Process Equipment Maintenance, Utilities Operation, Manufacturing Systems and Validation. The team is expected to perform all duties in compliance with Good Manufacturing Practices (cGMPs).
This leader will foster strong working relationships with each functional group (Manufacturing, Technical Services, Quality Assurance, Quality Control and Supply Chain) to ensure reliable production across the network. The successful candidate must have the ability to balance deeply technical and complicated matters while delivering world class service through cross functional teamwork.
- Ensure that HVAC, utilities, process equipment and process automation are appropriately and safely maintained, validated and approved for manufacturing activities.
- Manage all engineering and facilities work to meet and optimize manufacturing or plant shutdown schedules while maintaining a high level of GMP compliance and cost efficiency.
- Ensure Engineering and Facilities teams initiate and complete investigation, deviations, CAPAs, and Change Controls as assigned.
- Maximize the success rate for production operations by instituting programs to minimize mechanical failure, closed-system breaches, and procedural errors.
- Manage the Business Continuity Plans for each site within the network and integrate where appropriate.
- Support all required Regulatory Affairs activities, including agency inspections. Provide expertise and leadership in formulating inspection responses.
- Support and identify strategic plans for process and plant improvements in order to increase efficiency and drive down costs.
- Drive implementation of engineering capital projects within budgets and timelines.
- Develop, implement, and own a comprehensive engineering strategy for the site that provides a 1-3-5 year vision, plan and direction for the site Engineering function.
- Communicate operational status regularly to the appropriate plant leadership team and to Global Operations, as required, at the appropriate level of detail. Communications will be both written documents, and formal and informal oral presentations.
- Drive continuous improvement of site validation strategy to meet increasing regulatory agency expectations.
- Build an engineering organization capable of delivering key projects for APIT and also supporting sustaining operations.
- Build and sustain employee engagement by creating a culture of inclusion and transparency in which individuals and teams can excel and continuously improve.
- Ensure appropriate training of personnel on equipment, process and facility safety procedures is maintained and up to date.
- Guide departmental personnel using effective performance reviews, training and development programs, setting and tracking goals and objectives.
- Motivate and develop staff to be leaders within College Park site and Alexion.
- Leverage the Integrated Management System to manage performance within each plant.
- Actively influence and participate in the Site Leadership Team while establishing a cross-functional leadership presence.
- Build and maintain strong and diverse relationships across the organization, including key client groups, peers, senior management, and subordinates.
- Fifteen or more years of managing Engineering and Maintenance functions for a GMP facility in the biotechnology industry.
- Demonstrated ability to build, organize and lead an engineering team to support a biopharmaceutical facility.
- Deep knowledge of regulatory requirements for commercial biopharmaceutical facilities.
- Proven ability to apply fundamental engineering principles to resolve a broad number of technical issues.
- Proven ability to prioritize critical versus non-critical issues with the ability to communicate the critical issues to management and associated teams in a clear and timely manner.
- Demonstrable quality of decision making at a senior engineering leadership level.
- Experienced in identifying real risks; coupled with the ability to prepare the necessary logical contingency plans and the ability to execute against the established plan.
- Experience directly leading multimillion dollar capital expense projects.
- Excellent communication skills (both written and verbal) with the ability to logically and concisely communicate complex issues to various audiences.
- Outstanding coaching and leadership skills in developing, motivating, and organizing high performing teams.
- Proven ability to develop leaders capable of growing within the department or other manufacturing and operations functions.
- Strong executive presence to appropriately represent Alexion in external or regulatory environments.
- Bachelor’s degree in Engineering required.
- Preference given to candidates with advanced degrees in chemical or mechanical engineering.
- 15 or more years of cGMP experience preferred with consideration given to other relevant experience and education.
- Cultivates innovation
- Being resilient
- Learning and self-development
- Decision quality
- Ensures accountability
- Strategic mindset
- Manages ambiguity and complexity
- Attracts and develops top talent
- Optimizes work processes
- Drives results
- Drives engagement
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
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.