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Job Description

About the Role:

Contributes to the successful implementation of system improvement projects and drives improvements around manufacturing KFA (key focus areas) goals including but not limited to people/safety, quality/regulatory/compliance, customer, financials, and operational excellence. Mentors and guides manufacturing staff on the purification processes, and controls around the processes.

Works as part of the Automation Engineering team to lead complex system improvement initiatives, support large-scale manufacturing projects. Partners closely with Process Engineering, Reliability Engineering, Maintenance and Manufacturing in troubleshooting the automated control processes, ensuring robust and compliant control systems aligned with cGMP requirements and Takeda Quality Systems standards.

Responsible for administration, maintenance, assessments, evaluations, troubleshooting, diagnostics, optimization and documentation of control systems.

Leads medium to large automation projects, defines scope, budgets, and timelines; provides advanced technical guidance to junior engineers, peers, and cross-functional partners.

Plans, schedules and leads project assignments using various engineering techniques, procedures and criteria with minimal guidance.

How you will Contribute:

• Implement systems to improve manufacturing KFAs by building a strong partnership with floor leadership. Drives value added results for the business by identifying improvement opportunities from the metrics and implementing them on a timely manner. If metrics do not exist, implement meaningful metrics for the business in a close partnership with floor leadership.

• Leads medium to large automation projects, including scope definition, design, budgeting, scheduling, commissioning, and qualification.

• Solves automation system and manufacturing equipment issues that result in production delays, and partners with other contacts support groups to ensure that the manufacturing process maintains a continuous flow. This support will include DeltaV, EBM, PLC/HMI, BAS, process, equipment, and instrumentation.

• Identifies improvement opportunities, supports automation roadmap, and contributes to risk assessment and validation planning. Implement a sustainable system and actions to prevent recurrence - this includes process and equipment issues.

• Owns and closes corrective actions related to the automation system; this includes but is not limited to Corrective Action & Preventative Action (CAPA) that are generated due to user interventions and non-conformances/events.Owns system(s) in the purification process and provides expert feedback for change notices, user interventions, and non-conformance investigations.

• Updates Standard Operation and Preventive Maintenance Procedures for the existing equipment and control systems.

• Leads the automation scope for large-scale programs and multiple small projects with complex features. Executes projects in accordance with the LA Plant Project Management Methodology guidelines and practices.

• Execute and actively participate in ownership of Project Records (PRs) , configuration changes, functional tests, Commissioning Plans, and Qualification Protocols.

• Supports PLC/HMI based control systems for various stand-alone equipment such as COP skids, Autoclave and Material Lifts, among others.

• Performs financial planning and assists in the analysis to justify project approval. Contributes to prioritization of automation projects. Reviews, continuously updates and standardizes control systems current technical documentation and drawings: User Requirement Specifications, Functional Specifications, Design Specifications, electrical/control drawings, control network diagrams, system configuration, control components h/w and s/w settings, panel layouts; BOMs, and Spare Parts lists.

• Conduct regular audits and revise SOPs/specifications to maintain a rigid connection between control system actions, installation processes, backups, restorations, and manual operations.

• Perform system administration activities for control systems.

• Develops and formally executes Control System/Equipment Installation, Operation, and Performance Commissioning protocols for modified or new equipment, ensuring successful integration into operations.

• Mentors junior engineers and provide technical guidance to cross-functional teams.

• Trains Instrumentation and Metrology technicians on control systems functionality, instrumentation configuration, troubleshooting and diagnostic methods and techniques. 

• Continuously trains Quality Operation, Compliance

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 may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.

• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.

• Work in a cold, wet environment.

• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

#GMSGQ  #ZR1  #LI-Onsite

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.

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U.S. Base Salary Range:

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, 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.

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