Process Engineering Manager

Takeda • Brooklyn Park, MN

1d

About The Position

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.

Requirements

• 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
• 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
• 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

Nice To Haves

• Experience leading project teams or managing people (preferred)
• Professional Engineer (PE) license (preferred)

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager