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Job Description

About the role:

As the Process 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 Process Equipment is “fit for purpose” for the manufacture of drug substance, while meeting Regulatory, Quality, Capacity and EHS requirements

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

• Provides leadership to 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 process 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

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.

• Technology Selection

  • Drive cross-functional stakeholder management with our Partners in Manufacturing e.g. Sciences and/or Pharmaceutical Sciences. Sponsor the evaluation and selection of new, state-of-the-art technologies and process equipment and and applicable process equipment vendors.

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

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

  • Manage Process 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 of Process Unit Operation Capacity models and identify capacity bottlenecks / constraints in GMP manufacturing processes / production process and in the utilities delivery systems

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

• Engineering and Equipment Design

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

  • Project Turnover Packages for Process 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 Process Basis of Designs, specifications and designs for Process Equipment, Process Control Systems, Process Instrumentation and Process Safety Systems and Devices

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

  • Commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment

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

  • Design Reviews of Process 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 process equipment with relation to EHS requirements and ensure relevant changes are implemented.

  • Investigate process equipment and implement Corrective and Preventive Actions (CAPA)

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

  • Provide leadership to the Manufacturing and Maintenance departments with troubleshooting activities of Process Equipment on the factory floor

  • Lead continuous improvement activities for Process Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and 3rd level troubleshooting in collaboration with “Manufacturing” & ”Manufacturing sciences”

  • Implement Change Management for Process Equipment in area of responsibility

  • Responsible for internal and regulatory Audits and Inspections

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

Minimum Requirements/Qualifications:

• Minimum of 8 years of work experience in the pharmaceutical or related industry.

• 5 years of people leadership experience preferred.

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

• 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.

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