Plant Engineering Lead

Full Time
Lexington, MA 02420
Posted
Job description

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Job Description

About the role:

As the Plant Engineering Lead, you will report into the Head of Site Engineering for MA Bio Ops. In this role you will:

  • Empower, develop, and support staff members to ensure Plant Equipment is “fit for purpose” for the manufacture of drug substance, while meeting Regulatory, Quality, Capacity and EHS requirements

  • Responsible for local carbon neutrality targets “mission zero”

  • Drive strategic preparation of sites for the future by introducing new technologies and delivering agile plant engineering solutions

  • Provides leadership to all engineering disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget

  • The incumbent is responsible to improve existing equipment to minimize production downtime. Provide leadership to all plant equipment related investigations

  • Develop and implement strategies to ensure cost and time effective designs while ensuring innovation and adhering to user requirements while managing daily operational support

  • Responsible to develop and implement an efficient operating model to manage site utility and building operations.

How you will contribute:

  • Leadership

    • Leadership expectations of this position include coaching and developing direct reports, ensuring adherence to performance management processes, and the implementation of departmental talent management and succession planning programs. Lead and inspire people while promoting a working culture that empowers and engages employees while stimulating a focus on quality, continuous improvement, collaboration, and innovation.

    • Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.

    • Integral member of the Site Engineering Leadership Team and works in collaboration with the team to drive Site Engineering strategic objectives.

    • In collaboration with the Engineering Leadership Team, lead the transformation of Engineering into a best-in-class organization that is fit for the future.

  • Utility and Facility Operations

    • Accountable to ensure that all site buildings, facilities, and utilities operate and are maintained in a safe, compliant, reliable, and efficient manner. This is accomplished through the management of both internal staff and under the structure of a performance-based contract with an IFM supplier.

  • Technology Selection

    • Drive cross-functional stakeholder management with our internal customers, acting as a consultant for available and future technologies. Sponsor the evaluation and selection of new, state-of-the-art technologies and building / facility / energy equipment and and applicable process equipment vendors.

    • Identify future industry trends and sponsor development of strategies for media equipment / technologies

    • Drive business case development for CAPEX investments in plant equipment incl. Total Cost of Ownership (TCO) calculations

    • Manage building / facility / energy Equipment Vendors and Architectural/Engineering firms in the delivery of CAPEX and OPEX projects in areas of responsibility

  • Capacity Modeling and Site Master Planning

    • Sponsor development building / facility / energy modeling and identify capacity bottlenecks / constraints in GMP areas and in the utilities delivery systems

    • Coach engineers in solving heat transfer, mass transfer, fluid dynamics, reaction kinetics to solve common plant engineering problems

  • Engineering and Equipment Design:

    • Front End Engineering and Design activities in feasibility study and conceptual design phases

    • Project Turnover Packages for plant equipment are delivered to site and that critical engineering knowledge such as as-built drawings, operating and maintenance manuals, equipment and instrument data sheets, spare parts lists are maintained, remain accurate and up to date

    • Gather requirements from Stakeholders - such as from Quality, Manufacturing, Reliability, Maintainability, Automation, and EHS – to develop conceptual, basic and detailed designs, specifications of equipment e.g. mechanical / electrical plumbing, civil / structural / architectural environment

    • Scope of Work and RFx Packages for Plant Equipment Vendors, Plant Engineering Consultants, Architectural / Engineering services, Commissioning services and (Sub-) Contractors

    • Commissioning activities such as Factory Acceptance and/or Site Acceptance testing of building / facility / energy equipment

    • With Partners in Engineering Validation develop the Qualification and Validation activities for Plant Equipment

    • Design Reviews of Plant Equipment with Stakeholders, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, Automation

  • Safety Engineering Design:

    • Conduct Process Hazard Analysis (e.g. PHA-Hazop) of hazardous manufacturing / production processes and incorporate improvements into the design of process equipment, process control, and process safety systems

    • Perform design reviews of all building / facility / energy equipment with relation to EHS requirements and ensure relevant changes are implemented.

    • Investigate building / facility / energy equipment and implement Corrective and Preventive Actions (CAPA)

    • Collaborate with insurance companies e.g fire codes and regulations, pressure safety design

  • “Factory Floor” Continuous Improvement/ Trouble-shooting / System ownership:

    • Provide leadership to the Manufacturing and Maintenance departments with troubleshooting activities of facility / utility systems

    • Lead continuous improvement activities for media / plant Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and 3rd level troubleshooting in collaboration with internal customers

    • Implement Change Management for Equipment in area of responsibility

    • Responsible for internal and regulatory Audits and Inspections

    • Engage in the Plant Engineering Community of Practice (CoP) through sharing of best practices and lessons learned

Minimum Requirements/Qualifications:

  • Engineering degree or equivalent required with a specialization in Chemical, Biochemical, Mechanical or Industrial engineering preferred

  • Minimum of 12 years of work experience in the pharmaceutical or related industry.

  • 10 years of people leadership experience preferred.

  • A strong leader capable of providing leadership to teams of Engineers and end users

  • Proven engineering experience in a GMP environment

  • Thorough knowledge of Process Unit Operations in Pharmaceutical Manufacturing

  • Strong interpersonal skills and communication abilities. Able to manage up and across the organization

  • Sound business acumen and ability to align engineering services with business needs and within financial constraints.

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision

  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

  • Health & Wellness programs including onsite flu shots and health screenings

  • Paid time off for vacation, sick leave, and volunteering

  • Community Outreach Programs and company match of charitable contributions

  • Family Planning Support

  • Professional development opportunities

  • Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

  • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

  • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

  • Work in a cold, wet environment.

  • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

  • Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

More About Us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Lexington - BIO OPS

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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