Senior Process Engineer

About The RoleServe as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)Ensure systems remain in a qualified state. Act as technical owner for system lifecycle including design, installation, qualification, production support, deviation resolution, maintenance, and decommissioningMonitor system reliability and performance. Develop and implement engineering solutions to complex problems. Lead programs related to system qualification, asset management, project execution, and Good Engineering Practices. Support development of site staff on technical and procedural topicsHow You Will ContributeDevelop engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional SpecificationsImplement system modifications under cGMP change controlDevelop and execute FAT, commissioning protocols, and qualification protocolsDevelop calibration and preventative maintenance plansLead deviation investigations and implement corrective and preventative actionsParticipate in capital planning, spending, and trackingServe as project manager on small to medium projects under $5MInterface with cross-functional teams to meet project goalsStay current with industry best practices and technologiesComplete required training within timeframeSelecting technologies, designing equipment, and diagnosing process issuesMaking data-driven decisions using engineering principlesEnsuring impact to product quality, safety, reliability, and throughputMaintaining regulatory compliance and validation requirementsTroubleshooting factory floor issues and supporting capacity planningManaging impact to uptime, batch continuity, and manufacturing scheduleResponding to urgency and severity of equipment failuresDetermining escalation thresholdsBalancing short-term mitigation versus long-term solutionsPerform other duties as assignedWhat You Bring To TakedaBachelor's degree in Engineering3 or more years of relevant experienceExperience in pharmaceutical or biotechnology manufacturing environmentEngineer-in-Training (EIT) or Professional Engineer license preferredDemonstrated track record supporting process operations and projects in an FDA-regulated environmentKnowledge of engineering principles including fluid mechanics, heat transfer, thermodynamics, and mass transferExperience applying project management methodologiesUnderstanding of commissioning and qualification protocol developmentDirect experience with systems such as bioreactors, centrifugation, chromatography, tangential flow filtration, CIP, autoclaves, clean utilities, and HVACFamiliarity with instrumentation and sensing technologies in pharmaceutical manufacturingExperience with regulatory requirements and GMP environmentsExperience supporting large capital projectsFamiliarity with batch control systems, data historians, SQL, and scripting (preferred)Knowledge of automation, PLCs, power systems, and controls (desirable)Proficient in MS Office (Word, Excel, PowerPoint) and MS ProjectAbility to work in fast-paced, cross-functional teamsStrong planning, prioritization, and escalation judgmentImportant ConsiderationsAt 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 may:Combination of sedentary work and facility walkdownsOccasional ladder climbingAbility to lift up to 25 lbsParticipation in 24/7 on-call rotationUse of PPE and clean room garments as requiredInfrequent travel up to approximately 25% during project activitiesMore About UsAt 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.LocationsBrooklyn Park, MNWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYes