Head of Engineering Programs (Westfield)

Compensation

: $94,360.00 - $141,170.00 /year *

Employment Type

: Full-Time

Industry

: Engineering



Head of Engineering Programs
Primary Duties
The Head of Engineering Programs will lead and manage engineering programs supporting manufacturing operations across the MA Bio Ops Site. Provides holistic engineering program design, development and deployment in support of commercial and clinical manufacturing across the Value Streams. Evaluates and manages capability and capacity of the Engineering Programs team to ensure consistent execution, performance and compliance with regulatory agencies. Builds continuous improvement into engineering programs to improve value delivery and streamline operations.
As a member of the MA Bio Ops Engineering Leadership Team (ELT), the Head of Engineering Programs will lead and drive programs supporting the operational requirements of commercial and clinical bulk drug substance manufacturing at the MA Bio Ops Site. The scope of the function will consist of the following:
* Validation - Equipment, Facilities and Utilities, Commissioning and Qualification, Computer System Validation, Process Validation, all aspects of the Validation Master Plan (VMP) and validation lifecycle management
* Reliability Engineering - program development and deployment, metrics and asset lifecycle management to ensure all assets are functioning as designed
* Engineering Programs and Documentation - engineering systems, procedures, sustainability and documentation to standardize and improve engineering processes
* Tech Transfer - technical and project support for new product introductions across the site, including integration of technical resources and collaboration with product leadership
Responsibilities:
40% of Time
* Responsible for performance management and professional development of the Engineering Programs leadership and team.
* Allocates resources, assigns priority to tasks and acts as an advisor to Site senior management in delivery of value-added services and programs for the Lexington Site.
* Manages budgets and contract resources.
20% of Time
* Provides management oversight to ensure the MA Bio Ops Validation, Reliability, Programs and Documentation and Tech Transfer functions are properly staffed, measured for performance, aligned with value delivery, and are compliant with all regulatory requirements.
* Ensure access to systems is adequate to meet manufacturing requirements.
* Provides management oversight of delivery of major program activities.
* Ensures organizational agility in order for timely response and resolution to program deployment issues.
20% of Time
* Accountable for development of technical subject matter expertise and provision of adequate engineering resources (internally and externally) to ensure delivery of compliant and robust engineered solutions to improve reliability and efficiency of systems and equipment based upon best practices and operational periodic reviews.
10% of Time
* Accountable functional partner and decision maker on the MA Bio Ops ELT.
* Aligns with ELT and direct reports on site strategy and goals, identifies and escalates Engineering issues, and informs team on deliverables to ensure continuous improvement and overall support of engineering programs.
10% of Time
* Accountable for the planning, execution and technical quality of deliverables for all site engineering programs and projects.
* 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
Essential:
* Bachelor's degree in Engineering and ten plus (10+) years of experience in an engineering and/or facilities function within a biotech/pharmaceutical operations/ manufacturing environment
* Five plus (5+) years of experience with direct management of people managers
* Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required.
* Experience with the clinical development lifecycle
* Experience with validation management, working knowledge of GAMP and 21 CFR requirements
* 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
Desired:
* Fifteen (15+) plus years of experience in management of engineering personnel and proven skills for the management of managers is preferred.
* Experience in operations leadership
* Experience with reliability engineering
* Experience working in a Lean or Value Stream environment
Key Skills, Abilities, and Competencies
* 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 Alewife Facilities & 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
Internal:
Facilities & Engineering at the Alewife site is a primary partner with Manufacturing, Quality, Supply Chain, Manufacturing Sciences and other support organizations supporting manufacturing at the Alewife site. The position will be a member of the Alewife Operations Leadership Team and the MA Bio Ops Engineering Leadership Team. Internal contacts include those in the Process Development, Supply Chain, Quality Control, Manufacturing, Validation, Quality Assurance, Materials Management, and above site Engineering functions. The Alewife 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 Site Engineering management to ensure clear and precise multi-plant cross-communication.
External:
* 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 MA Bio Ops 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 -
EEO is the Law - Supplement -
Pay Transparency Policy -
Reasonable Accommodations
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-###-#### and let us know the nature of your request and your contact information.
United States - Lexington MA

* Bachelor's degree in Engineering and ten plus (10+) years of experience in an engineering and/or facilities function within a biotech/pharmaceutical operations/ manufacturing environment * Five plus (5+) years of experience with direct management of people managers * Demonstrated experience in bioprocess engineering and expert knowledge of systems/equipment/facilities/automation is required. * Experience with the clinical development lifecycle * Experience with validation management, working knowledge of GAMP and 21 CFR requirements * 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 Desired: * Fifteen (15+) plus years of experience in management of engineering personnel and proven skills for the management of managers is preferred. * Experience in operations leadership * Experience with reliability engineering * Experience working in a Lean or Value Stream environment Key Skills, Abilities, and Competencies * 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 Alewife Facilities & 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., * 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 MA Bio Ops 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., EEO is the Law -

EEO is the Law - Supplement - Pay Transparency Policy - Reasonable Accommodations 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-###-#### and let us know the nature of your request and your contact information.


Associated topics: bioengineering, biology, biomaterials, genetic, neuro, neurodegenerative, nutrition, pain, pathogenesis, therapeutic * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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