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Job Description

About the role

You will manage the automation strategy, implementation plan, software development, and systems integration, specializing in Electronic Batch Management (EBM) / Manufacturing Execution System (MES). Be a site EBM Subject Matter Expert (SME) and collaborate with Global / Local MES and Automation technical teams to ensure agreement and fulfill strategic objectives. Exhibits creativity and progress in completing divisional and department responsibilities. Utilize technical expertise to manage high-visibility projects and resolve complex issues. Analyze business processes, evaluate, and design/redesign procedures to meet user requirements. Provide guidance and direction to Takeda employees and contractors to meet schedule and financial goals while ensuring technical success. Lead scope definition, conceptual design, specifications, budgeting, scheduling, commissioning, and production support. Provide guidance, review, and direction to create functional Life Cycle and other documentation per cGMPs and Takeda Quality Systems standards.

How you will contribute

• Lead large-scale programs, and multiple small projects with complex features.

• Plan and schedule project implementation.

• Define the scope of work for the project team, commissioning, and validation support.

• Perform financial planning and assist in the analysis to justify project approval.

• Review proposals to determine if benefits derived and possible applications justify expenditures.

• Coordinate status, solutions, and opportunities with other departments to ensure successful implementation of the design. Understand appropriate SDLC, SOPs, quality validation processes, and regulatory requirements for all system update actions.

• Lead the EBM system code development and for multiple scale level projects.

• Gather, understand, and document business user requirements, including overall objectives and process specifications.

• Align requirements with software and system capabilities and provide business partners with solutions.

• Develop test cases, scripts, and protocols that sufficiently document understanding between code and business requirements.

• Maintain all system functional and design specifications according to quality system procedure and regulatory requirements.

• Provide guidance and training on MES system procedures and standards to internal and external team members.

• Solve MES system issues that result in product impact and production delays; coordinate and contact support groups for assistance. This support will include CAPA investigation involvement and task ownership. Recommend and implement actions to prevent recurrence. Manage and oversee Trackwise Project Records associated with system requirements resulting from investigations or issues.

What you bring to Takeda

• Bachelor's degree in engineering discipline required.Computer, Chemical, Mechanical, Electrical Engineering Degree Preferred.3+ years of related experience. Some leadership experience preferred for supervisory roles.

• Experience managing MES systems in an FDA regulated manufacturing settings.

• Knowledge of GMPs, FDA guidelines and validation.

• Maintain industry contracts and be involved in industry interest groups.

• 3+ years of experience in process design, controls engineering and process improvement.

• Knowledge of MES (Siemens Opcenter Execution Pharma).

Important Considerations

• Must be able to lift, push, pull and carry up to 25 lbs.

• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.

• Will work in controlled environments requiring special gowning. Will 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 environment.

• Must be able to work multiple shifts, including weekends.

• May work in a confined area.

• Some Clean Room and cool/hot storage conditions.

• Will work in demolition/construction area.

• Must be able to work 100% 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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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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