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Takeda Pharmaceuticals Associate Director, Global Plant Engineering (Hybrid) in Lexington, Massachusetts

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Job Description

Job Title: Associate Director, Global Plant Engineering (Hybrid-US)

Reports to: Head of Engineering Program Management

Location : Lexington, MA (Hybrid) / Zurich, Switzerland

About the role:

  • Provide global subject-matter-expertise for facilities and utilities design and operation against best-in-class benchmarks (for systems including HVAC and refrigeration, clean rooms, and GMP and Non-GMP utility systems)

  • Leads plant engineering community of practice ( CoP ) with a team of global and site engineering leaders to harmonize and improve plant utilities and HVAC/R systems for cost-effectiveness, and environmental sustainability, including strategies and roadmaps for implementing new plant technologies

  • Define and own global standards for utilities and facilities systems and operations

  • Be the technical authority to support utilities and facilities technical and quality events and investigations into plant utilities and facilities design and operation

How you will contribute:

  • Lead and establish plant engineering communities of practice ( CoP ), leading to harmonized plant engineering across manufacturing sites and ensuring sharing and application of best practices and expertise

  • Provide global leadership to develop engineering standards for important utility and HVAC/R systems design and operation

  • Scouts creative technology solutions for manufacturing network utilities and HVAC/R systems and guides risk-based assessment and implementation; develops strategy and roadmaps for the global introduction of new technologies

  • Develop guidelines that support sustainability, and lifecycle management strategies for plant systems

  • Provide technical support to CAPEX investment projects and investment applications

  • Subject-matter-expertise in quality and technical-related events relating to utility and HVAC/R systems and participates in an investigation or audit support.

Technical/Functional (Line) Expertise: Subject matter expert in utilities, HVAC/R, and clean room design and operations with hands-on working experience with facilities equipment and important utility systems – Clean Steam, Water for Injection (WFI), Purified Water (PW), and Process Compressed Air/Vacuum, in addition to Black Utilities such as Plant Steam, Boilers, Industrial Heat Pumps, Wastewater Systems, Cooling and Chilled Water, Water Softeners, specialty gasses (e.g. O2, N2, CO2), and Electrical Generators and Distribution Systems. In-depth regulatory, quality, and engineering expertise in bio-pharmaceutical manufacturing environments. Knowledge of GMP, FDA/EMA guidelines, and system validation

Leadership : Excellent partner with change management skills; Lead diverse teams with empowering leadership style that gains results; Lead road map efforts to test/pilot, recommend and implement important areas of technologies collaborating with all partners with service excellence, with a first mindset and having collaboration skills

Decision-making and Autonomy: Work with important partners to develop business cases and deliver benefits realization; Work with multiple partners to recommend important technology solutions to leadership; Provide technical expertise and be accountable for successful execution plans

Interaction: Identify trends and developments in utilities and facilities for proper evaluation; Experienced in working in an intercultural, diverse team; global, regional, and site teams; Can make value proposition case to important leadership and team members; Lead Site/OpU/Region Engineering Center of Practice (CoP) forums and teams; Works with organizations outside of Takeda to understand industry trends and best technology and practices

Innovation: Demonstrated subject-matter-expertise in areas of engineering and utilities; Make risk-based decisions and set plans to monitor, communicate, and mitigate risks; Lead conversation on industry trends with industry peers and presented at industry forums (e.g., ISPE, PDA)

Complexity: Navigate regulatory challenges and have familiarity with global requirements for utilities and facilities design, operations, and maintenance; Achieve results in a function leadership role in a matrixed organization

What you bring to Takeda:

Essential Skills:

  • Technical, Scientific, or Engineering degree with 10+ years of technical experience in biopharmaceutical engineering

  • Demonstrated expertise in utilities, HVAC and Refrigeration, and clean room design, operation, and maintenance

  • Experience with associated regulatory and quality requirements for utilities and HVAC

  • Team building and team leadership

  • Travel Required (Approx. 20%, domestic and international

Desired Skills:

  • An advanced degree in a scientific/technical discipline

  • Technical knowledge of Plasma Derived, Biologics, and Small Molecule facility, engineering, and manufacturing process

  • Experience with newer engineering technologies supporting manufacturing

  • Knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE, and PDA Guidance Documents

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

  • Generous time off for vacation and the option to purchase additional vacation days

  • Community Outreach Programs and a company match of charitable contributions

  • Family Planning Support

  • Professional training and developmental opportunities

  • Tuition reimbursement

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.

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 to inspire and empowers 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.

#GMSGQ

#ZR1

#LI-Hybrid

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

Lexington, MA

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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