Process Engineering Manager

Responsibilities

• Serve as a subject matter expert for process unit operations, ensuring equipment is fit for purpose in drug substance and drug product manufacturing.
• Lead the full lifecycle management of process systems, including design, installation, qualification, maintenance, and decommissioning.
• Drive continuous improvement initiatives using tools such as DMAIC, FMEA, and RCA to enhance equipment reliability and throughput.
• Partner cross-functionally with Manufacturing and Pharmaceutical Sciences to evaluate and select advanced process equipment and vendors.
• Manage CAPEX and OPEX projects, including developing business cases, ROI analyses, and managing engineering partners.
• Lead process hazard analyses (e.g., HAZOP) and incorporate risk-reduction strategies into equipment designs.
• Provide technical leadership and troubleshooting support to Manufacturing and Maintenance teams on the production floor.
• Develop capacity models to identify bottlenecks and support site master planning.

Requirements

• Bachelor's or Master's degree in Engineering or a related scientific discipline.
• 7+ years of engineering experience with increasing responsibility.
• 5+ years of experience in 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, chromatography, TFF, centrifugation, or CIP systems.

Preferred Qualifications

• Experience leading project teams or managing people.
• Professional Engineer (PE) license.
• Knowledge of process automation, PLCs, instrumentation, and controls.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off and well-being benefits.
• Paid vacation and sick time.

About the Company

Takeda is an industry-leading, global pharmaceutical company dedicated to putting patients at the center of everything they do. Driven by the values of Integrity, Fairness, Honesty, and Perseverance, Takeda strives to deliver better health and a brighter future through leading innovation in medicine.