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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 high-performing 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 cross-functionally 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 long-term 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 as-built 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 risk-reduction strategies into equipment and control system designs
Conduct EHS-focused 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
Bachelor's or Master's 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 fast-paced, cross-functional 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 data-driven 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 short-term mitigation with long-term 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 product. In 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.
#GMSGQ #LI-FM1
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: Brooklyn Park, MN
U.S. Base Salary Range: $111,800.00 - $175,670.00
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 job. 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 or 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
Brooklyn Park, MN
Worker Type Employee
Worker Sub-Type Regular
Time Type Full time
Job Exempt Yes