Director - Engineering - Alexion Pharmaceuticals - Smithfield

Job description
Director, Engineering
Reports to: Senior Director, Technical Management Services
Location: Smithfield, Rhode Island
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.

Position Summary

The Director of Engineering is responsible for all engineering activities at the Alexion Rhode Island Manufacturing Facility (ARIMF) for commercial and clinical products. The responsibility includes process engineering, facilities and utilities engineering, and process automation. This position will be the owner of clean-in-place and sterilize-in-place design, equipment and general engineering procedures. This position will manage a group of 10 engineers and managers of varying experience.

The position will manage engineering support of 24 × 7 manufacturing operations; fostering effective cross-functional working relationships with Manufacturing, Technical Services, Facilities, Validation, Logistics, Quality Assurance and Quality Control groups which support day-to-day operations; and providing support for Regulatory inspections/submissions related to commercial and clinical products manufactured at this facility. Success is measured by smooth installation and ongoing operation of: utilities, process equipment, and automation. This Director is expected to perform all duties in compliance with Good Manufacturing Practices (cGMPs) and in accordance with ARIMF facility SOPs. The Engineering team is also responsible for initiation and completion of deviations, CAPAs and Change Controls as assigned. The Director will make an efficient and effective use of resources, have a well-managed staff, and have an effective collaboration with customer and supporting departments. The Director will also plan, budget and schedule facility/system modifications.

Principal Responsibilities

Plan and manage day-to-day engineering support work to meet manufacturing or plant shutdown schedules while maintaining a high level of GMP compliance and being cost efficient.
Develop and continually update an Engineering and Automation project schedules on a weekly monthly and quarterly basis and ensure alignment/adjustment of manufacturing schedule to meet corporate goals and metrics, as required. This includes continuous communication with Quality, Manufacturing and other technical groups to ensure efficient management of Alexion’s commercial and clinical drug substance manufacturing activities.
Ensure that utilities, process equipment and process automation are appropriately maintained, validated and approved for manufacturing activities. Ensure appropriate training of personnel on equipment, process and facility safety procedures is maintained and up to date.
Responsible for initiation and completion of deviations, CAPAs, and Change Controls as assigned. Performs investigations relating to equipment malfunctions using Alexion’s Quality systems.
Maintain a high, and continuously improving, level of cGMP compliance to ensure patient safety and to minimize risk to the company business. Support Regulatory licensure activities, including agency inspections. Provide expertise and leadership in formulating inspection responses.
Motivate, recruit and develop key employees. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
Maximize the success rate for production operations by instituting programs to minimize mechanical failure, closed-system breaches, and procedural errors. Support strategic plans for process and plant improvements in order to increase efficiency and drive down costs.
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.
Drive implementation of engineering capital projects within budgets and timelines.
Motivate and develop supervisors and managers to be key leaders within ARIMF and Alexion.
Provide the long and short-term strategic vision, plan and direction for the Engineering function. Guide departmental personnel using effective performance reviews, training and development programs, setting and tracking goals and objectives.
Maintain a high level of compliance and efficiency to drive the organization to world-class biotechnology manufacturing standards.
Actively influencing and participating in the ARIMF Site Leadership Team and establishing a cross-functional leadership presence.
Develop, implement, and own a comprehensive engineering strategy for the site.
Build and maintain strong and diverse relationships across the organization, including key client groups, peers, senior management, and subordinates

Qualifications

Twelve plus years of managing Engineering function for a GMP facility in the biotechnology industry.
Deep knowledge of regulatory requirements for clinical and commercial biopharmaceutical facilities.
Demonstrated leadership skills in developing, motivating, and organizing high performance work groups in the biotechnology industry.
Ability to apply fundamental engineering principals to resolve issues relating to processing equipment, scale, technology transfer and related changes
Must be able to prioritize critical versus non-critical issues, and communicate the critical issues to management and team leaders in a clear and timely manner
Ability to see the big picture; to prepare contingency plans and ensure execution of plans through effective organizational delegation
Excellent communication skills—both upwards and downwards and outside the company. Ability to lead and communicate orally, in written documents, and in formal presentations is required

Education
Bachelor’s degree required; preference given to candidates with advanced degrees and degrees in chemical or mechanical engineering or related field; 12 or more years of cGMP experience preferred; consideration will be given to other relevant experience and education.

Competencies
Core Competencies

Accountability
Collaboration
Decision Quality
Drive for Results
Perseverance
Problem Solving

People Manager Competencies

Developing Direct Reports and Others
Hiring and Staffing
Managing Performance
Motivating Others

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