The Site Engineering Leader will lead and manage the engineering operations for manufacturing operations at MA Bio sites. Provides holistic engineering and maintenance support to the sites and sustainably achieve capacity plans and fulfillment targets. Maintains equipment and facilities, performs facilities management including operations of utilities and critical systems, provides engineering technical support, and capital planning and execution. The position will report directly to the MA Bio Site Lead and serve as a standing member of the MA Bio Site Leadership Team, which helps set strategic direction for the site engineering organization and is accountable for operating results. In addition, the positions serves as a member of the Biologics OpU Engineering Network level Leadership Team working very closely with the Global Engineering Leader of the Bio OpU.
As a key decision maker on the site leadership team, the Head of Site Engineering will lead and drive the Engineering function supporting the operational requirements of commercial and clinical bulk drug substance manufacturing at the MA Bio (Lexington & Alewife) Campuses. The scope of the function will consist of:
- Maintenance, Utilities, and Calibration
- Process Engineering
- Plant Engineering and Utilities
- Automation Engineering
- Site Capital Engineering Projects
- Engineering Programs, Business, and Operational Support Services
- Facilities and Site Services supporting the entire campus including oversight of 3rd party providers
The Head of Site Engineering will ensure the operation, maintenance, and utilities for all equipment, and utility systems used to support manufacturing operations at the MA Bio sites. Including the non-manufacturing facilities on the campus (Medical Devices, Mfg. Science, Pilot Plant, QC Labs, Cell Banking) facilities.
The Head of Engineering is responsible and accountable for:
- Ensuring Facilities, Plants, Utilities and Equipment are properly maintained and are fit for intended use.
- Ensuring Facilities, Plants, Utilities and Equipment are operated in a safe and efficient manner and is compliant with all regulatory requirements
- Delivering compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon operational best practices and periodic reviews
- Developing and manage technical and organizational agility for timely response and resolution to operational issues.
- Developing talent and professional capabilities of the function.
- Responsible for performance management and professional development of direct reports. Accountable for performance management and professional development of the Lexington site Facilities and Engineering personnel. Allocates resources, assigns priority to tasks and acts as an advisor to Site senior management in delivery of value-added services for the Lexington Site. Manages budgets and contract resources.
- Provides management oversight to ensure the Lexington Site Facilities, Plants, Utilities and Equipment are properly maintained, fit for intended use, operated in a safe and efficient manner, and is compliant with all regulatory requirements. Ensures equipment availability is adequate to meet manufacturing requirements. Provides management oversight of delivery of coordinated major maintenance activities including scheduled plant shutdowns. Ensures organizational agility in order for timely response and resolution to operational issues.
- Accountable for development of technical subject matter expertise and provision of adequate engineering resources (internally and externally) to ensure system reliability, robustness and maximum availability. Ensures delivery of compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon best practices and operational periodic reviews.
- Accountable functional partner and decision maker on the Lexington site cross-functional governance team as well as the Global Biologics OpU Engineering Leadership team. Aligns on site strategy and goals, and identifies and escalates Engineering issues, and informs team on deliverables to ensure continuous improvement and overall support related to manufacturing operations support.
- Accountable for the planning, execution, controls, and technical quality of deliverables for all site capital investment projects and technology transfers. Ensure that project sub-teams are resourced appropriately (internally and externally) to meet their goals and objectives and ensure that projects are on time and on budget.
Education and Experience Requirements
- Bachelor s degree in Engineering and fifteen plus (15+) years of experience in an engineering and/or facilities function within a biotech/pharmaceutical operations/ manufacturing environment. Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required.
- Twelve (12+) plus years of experience in management of engineering personnel and proven skills for the management of managers is preferred. Excellent communication, technical, organizational, leadership, and mentoring skills are required. Must be a team player prepared to lead, work in, and embrace a team-based culture.
Key Skills, Abilities, and Competencies
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
- Be Positive
- Be Accountable
- Be Results Oriented
- Be An Excellent Manager of Self and Others
- Problem Solving: Enlists sound judgment and implements analytical, creative approaches to solve complex problems. Demonstrates innovative problem solving and analytical skills.
- Team and Talent Development: Builds, mentors and coaches the Biologics Operating Unit Engineering team. Must possess strong leadership, team building and management skills. Acts as a positive, resilient and collaborative leader with a can do approach.
- Business Acumen: Has a high level of business acumen and knowledge of the pharmaceutical industry. Has the necessary business knowledge to work with outside groups, such as HR, Finance and Legal.
- Communication: Develops and maintains strong relationships at various levels with partners. Influences key internal and external stakeholders. Utilizes excellent interpersonal skills to communicate at all levels and achieve outcomes.
Complexity and Problem Solving
- Establishes assignments in the form of objectives and goals to team members. Provides management guidance to subordinates on prioritization and resource allocation to achieve goals in accordance with established policies. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which affect direct functional organization and other organizations. Participates in the development of overall objectives and long range goals of Facilities and Engineering
- Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates to meet schedules and/or resolve technical problems. Develops and administers budgets, schedules, and performance requirements
- Functions as an advisor to a team regarding tasks, projects, and operations. Becomes actively involved in daily operations when required to meet schedules or to resolve complex problems
- Responsible for all activities/projects assigned to the engineering function. Manages highly skilled professionals and managers
- Ensures that engineering projects are completed on schedule and within budget by providing effective sponsorship and adequate support to execution of all project activities. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds
Internal and External Contacts
The primary client of Site Engineering is Manufacturing and support organizations supporting the manufacturing at the Lexington site. The position will be a member of the Lexington site leadership team and the Biologics OpU Engineering Leadership Team. Internal contacts include those in the Process Development, Supply Chain, Quality Control, Manufacturing, Validation, Quality, Materials Management, and above site Engineering functions. The Lexington Site Head of Engineering will meet with Manufacturing and support organization management and other internal contacts on a regular basis ensuring:
- Performance of facilities and engineering managers and personnel on projects / site operations meets the defined roles, responsibilities and standards.
- Site operations are adequately resourced to ensure a quality result and to meet customer requirements.
- Progress toward goals/milestones is reported out to the internal teams as well as the Engineering management to ensure clear and precise multi-plant cross-communication.
- Maintains external contacts with facilities and engineering service providers and vendors. Manages external vendor POs and accrual of expenses.
- Represents the overall Engineering function to regulatory agencies and other external contacts at the Massachusetts site.
Other Job Requirements
- This position requires the ability to communicate clearly and accurately, verbally and in writing and a strong understanding and knowledge of engineering and maintenance functions.
- Ability to work in a fast-paced environment and handle multiple tasks simultaneously.
- The ability to travel and work across all Lexington facilities.
- The candidate will be expected to evaluate and prioritize activities to support the business and add value to the company while understanding the specific priorities at the Lexington site.
- Candidate will be required to carry a cellular device and be available to support production requirements at the Lexington site.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.