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Associate Director, Operations Technology - MES
This person will be a key leader and contributor in the conceptual design, detailed design, specification, implementation, qualification, trouble-shooting, and continuous improvement of manufacturing IT/OT systems for biopharmaceutical production and development facilities. Also, they will be a primary liaison between Manufacturing, IT and Facility clients, global partners, and external vendor resources.
Responsibilities: Job Function and Description
- Architects and leads the implementation of Manufacturing Execution System (MES) projects for MA Biologics Operations
- Architects and leads the implementation of various system integration projects for MA Biologics Operations
- Independently leads multi-discipline teams on mega-projects or programs of high complexity
- Conducts customer/project workshops, utilizing Takeda’s MES deployment framework, to analyze user requirements and to define functional requirements for MES solutions through client interviews and documentation analysis
- Develops detailed designs, implements, troubleshoots and tests MES and associated system integration solutions that meet client requirements
- Provides functional and project execution leadership and mentors direct reports and project members
- Acts internally and externally 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. Capable of directing the activities of multiple Lead Engineers, Technical Consultants, or Senior Technical Consultants
- Directs discussions determining strategic operating policies or technical direction, devising ways of reaching objectives in the most economical manner and of solving unusual complex technical problems involving several disciplines
- Develops and improves processes, procedures and tools used in the execution of projects
- Works with manufacturing, facilities, science & technology groups to influence long-term manufacturing plans and strategies
Education and Experience Requirements
- BS degree with minimum of 12 years overall experience, including a minimum of 10+ years project experience, and at least 8 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.
- Demonstrates understanding of Windows OS, Networking & System Security Fundamentals as well as knowledge of S88, S95, OPC, Data Historian, System Interfaces, Distributed Control Systems, etc.
Key Skills, Abilities, and Competencies
- Strong understanding of Data Integrity (per FDA and EMA)
- Effective verbal and written communication skills
- Able to effectively manage the system lifecycle of assets and components
- Ability to effectively document and specify system specifications; both new from the ground up, and changes to existing systems
- Experience with current trends in automation and manufacturing IT to be able to select and implement modern architectures and design solutions
- Strong verbal and written communication skills required
- Excellent interpersonal skills required
- Adherence to domestic and international GMP regulations
- Strong organizational and teamwork skills
- Ability to multi-task in a dynamic environment with changing priorities
- Proficiency with Microsoft products; ability to learn additional software applications, as the need arises – TrackWise and Maximo experience a plus.
Complexity and Problem Solving
- Individual must be capable of performing assignments that have loosely defined objectives that require investigation of a large number of variables.
- Can function as a technical expert to equipment and systems regarding troubleshooting and operations.
- Ability to apply diversified knowledge of engineering principles and practices to a broad variety of assignments and related fields.
- Work with cross-functional groups in developing requirements and recommendations for highly complex automation system modifications.
- Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Complete understanding and application of principles, concepts, practices, and standards.
- Full knowledge of industry practices.
- Work is performed under general direction.
- Participates in determining objectives of assignment.
- Plan schedules and arranges own activities in accomplishing objectives.
- Work is reviewed upon completion for adequacy in meeting objectives.
Internal and External Contacts
- Exerts some influence on the overall objectives and long-range goals of the organization
- Internal and External Contacts:
- In addition to working closely with members of the Engineering Technical Support (ETS) Group and external Engineering resources, this individual will have regular contact with Manufacturing, IT and Facility clients.
- The candidate must be able to integrate the Validation and Quality department requirements into all aspects of the daily routine.
- Networks with key contacts outside own area of expertise.
- Serves as consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, plans, and objectives.
Other Job Requirements
- Ability to work at all Takeda MA locations (Cambridge, N Reading, Belmont and Lexington)
This job posting excludes CO applicants
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.