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Job Description

About the role

The Process Engineering Manager serves as a subject matter expert for process unit operations within pharmaceutical manufacturing. This role is responsible for ensuring process equipment is fit for purpose for drug substance and drug product manufacturing while meeting all regulatory quality capacity and EHS requirements. The role leads the full lifecycle management of assigned process systems including design installation qualification production support deviation resolution maintenance and eventual decommissioning.

This position drives continuous improvement initiatives by overseeing equipment reliability performance monitoring and system optimization to reduce downtime and enhance manufacturing throughput. The Process Engineering Manager develops and implements robust engineering solutions to complex technical and operational challenges while providing strong people leadership through hiring coaching and developing a highperforming team of Process Engineers.

How you will contribute

Continuous Improvement Troubleshooting & System Ownership

• Apply engineering expertise in heat transfer mass transfer fluid dynamics and reaction kinetics to diagnose and resolve complex process engineering challenges

• Provide leadership to Manufacturing and Maintenance teams during troubleshooting and issue resolution on the production floor

• Serve as system owner and lead continuous improvement initiatives using tools such as DMAIC FMEA and RCA

• Identify design and implement improvements that enhance equipment performance reliability and operational efficiency

• Monitor departmental metrics and present performance updates to site leadership

• Respond with urgency to equipment issues impacting manufacturing continuity or product quality

Technology Selection & Capital Project Support

• Partner crossfunctionally with Manufacturing Manufacturing Sciences and Pharmaceutical Sciences to align on technology needs and readiness

• Lead evaluation and selection of advanced process equipment and qualified vendors

• Identify emerging industry trends and define longterm strategies for process equipment and technology adoption

• Develop CAPEX business cases including total cost of ownership and ROI analyses

• Manage process equipment vendors and engineering partners to deliver CAPEX and OPEX projects

Engineering & Equipment Design

• Lead or support feasibility assessments and full lifecycle implementation of process and equipment engineering projects

• Ensure accurate and complete delivery of project turnover packages including asbuilt drawings maintenance documentation and spare parts data

• Develop system user requirements classifications technical specifications and scopes of work

• Create RFx packages for vendors consultants commissioning agents and contractors

• Support commissioning activities including FAT and SAT

• Support qualification and validation activities for process equipment

• Conduct design reviews with Quality Manufacturing Utilities Maintenance Reliability Calibration and Automation stakeholders

Process Safety Engineering

• Lead process hazard analyses (e.g. HAZOP) for hazardous manufacturing processes

• Incorporate riskreduction strategies into equipment and control system designs

• Conduct EHSfocused design reviews to improve process and equipment safety

• Lead investigations related to process equipment performance and implement effective CAPAs

Capacity Modeling & Site Master Planning

• Develop and support process material balances

• Build and utilize process unit operation capacity models to identify bottlenecks and constraints

• Mentor others in capacity modeling and support GMP manufacturing and utility planning decisions

Audit & Inspection Support

• Provide technical expertise and documentation support during internal and regulatory audits and inspections

• Ensure operational readiness for assigned systems and equipment

What you bring to Takeda

Education and Experience

• Bachelors or Masters degree in Engineering or a related scientific discipline

• 8 years of engineering or related experience with increasing responsibility

• 5 years supporting pharmaceutical or biotechnology regulated manufacturing environments

• Experience leading project teams or managing people (preferred)

• Professional Engineer (PE) license (preferred)

Key Skills Abilities and Competencies

• Strong foundational knowledge of fluid mechanics heat transfer thermodynamics and mass transfer

• Familiarity with cGMP requirements and regulated manufacturing environments

• Experience supporting or designing systems such as bioreactors centrifugation chromatography TFF CIP systems and autoclaves

• Knowledge of process automation PLCs instrumentation and controls (highly desirable)

• Proficiency with MS Office (Word Excel PowerPoint) and MS Project

• Ability to work effectively in fastpaced crossfunctional environments

• Strong planning and prioritization skills with sound escalation judgment

Complexity and Problem Solving

• Make technical decisions related to technology selection equipment design and process troubleshooting

• Apply datadriven engineering principles to ensure product quality safety reliability and throughput

• Balance regulatory and validation requirements with operational needs

• Make operational decisions during troubleshooting capacity planning and manufacturing support

• Assess severity and urgency of equipment failures and determine appropriate escalation

• Balance shortterm mitigation with longterm corrective solutions

Internal and External Collaboration

• Partner with site teams including Operations Automation Engineering Manufacturing Sciences Supply Chain Maintenance Metrology and Quality

• Participate in global engineering communities of practice

• Collaborate with external vendors and service providers

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 this role you:

Physical Demands:

• In general the position requires a combination of sedentary work and walking throughout the facility.

• May occasionally climb ladders.

• May be required to lift up to 25lbs.

• Other / Travel Requirements:

• Requires participation in 24/7 on-call support rotation with other automation and process engineering personnel.

• May occasionally be required to wear personal protective equipment (PPE) and other clean room garments. This may include safety shoes safety glasses aprons face shields lab coats full body gowns booties hair nets and gloves and hearing protection. Removal of makeup and jewelry would also be required at times.

• Infrequent travel but may approach 25% during project activities.

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.

Empowering our people to shine:

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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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

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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Job Exempt