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Job Description

Job Title: Senior MES Specialist

Location: Lexington, MA

About the role:

As a Senior MES Specialist, you will be a leader and contributor in the conceptual design, detailed design, specification, implementation, qualification, trouble-shooting, and continuous improvement of manufacturing systems for biopharmaceutical production and development facilities. You will be the liaison between Manufacturing, IT and Facility clients, global partners, and external vendor resources. You will report to the MES Business Owner.

How you will contribute:

• Subject Matter expert for Manufacturing Execution System (MES) projects for MA Biologics Operations.

• Help implement multiple system integration projects for MA Biologics Operations.

• Conduct or participate in customer/project workshops, using Takeda's MES deployment framework, to analyze user requirements and to define functional requirements for Master Batch Record (MBR) implementation through client interviews and documentation analysis.

• Develop detailed designs, implement, troubleshoot and test MBRs and MES configuration with associated system integration solutions to meet client requirements.

• Act internally as an industry-wide expert in manufacturing execution and information systems.

• Accountable for the successful application of technology in the organization and for developing customer relationships.

• Direct discussions determining strategic operating policies or technical direction, creating ways of reaching goals in the most economical manner and of solving unusual complex technical problems involving several disciplines

• Develop and improve processes, procedures and tools used in the execution of projects.

• Work with manufacturing, facilities, science and technology groups to influence long-term manufacturing plans and strategies.

• Provide manufacturing operations support for MES.

• Perform assignments that have loosely defined goals that require investigation of many variables.

• Be a technical expert to equipment and systems regarding troubleshooting and operations.

• Apply diversified knowledge of engineering principles and practices to a broad variety of assignments and related fields.

• Work with teams in developing requirements and recommendations for complex automation system modifications.

• Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

• Select methods and techniques for obtaining solutions.

• Complete understanding and application of principles, concepts, practices, and standards.

• work with members of the Engineering and Data, Digital and Technologies groups, you will collaborate with Manufacturing, Facilities, Process Engineering, Quality, Manufacturing Sciences and others.

• Integrate the Validation and Quality department requirements into the daily routine.

• Network with important contacts outside own area of expertise.

• Be the consultant to management and external spokesperson for us on major matters of its policies, plans, and objectives.

What you bring to Takeda:

• BS degree with minimum of 5 years overall experience, including at least 2 years' experience working on MES projects in the Life Sciences industry.

• Deployment experience with plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Syncade, Rockwell, ProPack Data, Werum PAS-X).

• Knowledgeable in FDA validation requirements preferred, including: User Requirement and Design Specs, Business Process Procedures, Design Reviews, Requirements gathering.

• Experience with SDLC (Waterfall/Agile).

• Experience developing user requirements, functional specification documents and test scripts for MES projects.

• Demonstrate understanding of Windows OS, Networking & System Security Fundamentals and knowledge of S88, S95, OPC, Data Historian, System Interfaces, Distributed Control Systems would be ideal.

• Understanding of Data Integrity (per FDA and EMA) in the context of manufacturing systems.

• Manage the lifecycle of electronic batch records.

• Follow domestic and international GMP regulations.

• Proficiency with Microsoft products; as the need arises – TrackWise and Maximo experience would be ideal.

• Work at all Takeda MA locations (Cambridge, N Reading, Belmont and Lexington).

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.

• 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.

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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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