Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-changing treatments for patients are deeply rooted in over 230 years of distinguished history in Japan.

“Every vial has a name” is a core value at our Thousand Oaks CA campus, a multiproduct facility with over 20 years of operational expertise.  We have an excellent opportunity for a high performing Sr. Process Engineer.  Under the direction of the Site Process Engineering Lead, contribute to engineering support for operations and projects.  Responsible for operational support with focus on Formulation and Filling. Utilize engineering principles to troubleshoot equipment issues, identify the root cause for equipment/process failures and variability. Identify process improvement opportunities and implement. Lead the technical aspect of investigations for equipment failures association with formulation and filling processes.

Support capital projects in the capacity of technical lead and/or project manager as required.

Act as an Engineering System Owner for assigned area.Identify process and equipment improvement opportunities; lead improvement projects through conception, implementation and completion/handover.Subject Matter Expert (SME) expected to guide and mentor junior engineering staff.Perform feasibility assessments for introduction of new processes and modification of existing processes. Make design recommendations.Execute capital and operational projects in the capacity of the engineering lead, and/or project manager as required.Contribute to creation of the Site Master PlanProvide technical expertise for troubleshooting manufacturing process and equipment problems.Monitor and report project costs including capital and cross-functional expenses. Estimate cost affected by design and/or policy changes. Contribute to creation of the site capital plan and long range plan.

Key Skills and Competencies

Familiarity with Formulation and Fillings processes, equipment and unit operationsFamiliarity with CIP, sterilization methods such as SIP and autoclave, lyophilizers, filling machines, capping machines and aseptic processing.Leadership and project management skills. Must have the ability to organize and present technical and project management overviews without assistance.Strong understanding of cGMP manufacturing and GEP.Must be able to provide solutions that reflect understanding business objectives and cost implications.Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.Must have good verbal/written communication skills

All Positions:

The position requires shift, weekend, and holiday work. Employee maybe required managing hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations.  Duties may include:  Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes. Demonstrated understanding and compliance in Standard Operating Systems, Current Good Manufacturing Processes (cGMP) & Good Documentation (GDP).Support planning and scheduling activities as directed.Requires familiarity with generally accepted building, plumbing, piping, electrical, and fire protection practices and codes to include NFPA, NEC, UBC, UMC and UPC in compliance with Takeda EH&S and Factory Mutual requirements.Must follow safety rules and ensure compliance with CA state and federal EPA regulation and laws. Specific responsible system repairs, upkeep, maintenance and operations managed within regulating agencies such as CAL OSHA and OSHA.Ensures personal Training Plan execution and compliance. Attends required training, meetings, and QWTs. Interact with and oversee contractor/vendor workEnsure safety, security, and the environment in all aspect of the daily activities and any potential safety hazardous are addressed and corrected immediately.Understand ergonomic relationship between people, equipment and working environment.Communication with customers, and daily communication and interaction with Supervisor regarding all daily activities.Adhere to all SOP’s during execution of daily work tasks.May be required to participate on call rotations for facilities/manufacturing/utilities support.Provides support for regulatory, partner and internal audits.May be responsible for development, revision and review of maintenance reports forms, records and/or procedures.Maybe provide training for staff as needed.Living our leadership behaviors is a basic expectation for all employees.

Leadership Behaviors

IntegrityFairnessHonestyPerseveranceBachelor's degree in Engineering discipline required. 8+ years of related experience.Demonstrated success in delivering results in several technical challenges.The candidate must have good communication skills and the ability to perform effectively in multi-disciplinary teams.In general, the position requires a combination of sedentary work and walking around observing conditions in the facilityMust be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.Will work in a cold, wet environmentMust be able to work multiple shifts, including weekends.Must be able to work overtime as required. (only for non-exempt positions)May be required to work in a confined area.Some Clean Room and cool/hot storage conditions.May be required to travel for business reasons, e.g. training or FAT.