Job Description

About the role:

You will be an important technical leader in the design, development, testing, deployment, and maintenance of data automation systems. Being a technical leader in the data automation group, they will provide advanced subject matter expertise and will architect solutions for data infrastructure, integration, and informatics. You will be a primary liaison between Manufacturing/Facility clients and external engineering resources.

How you will contribute:

• Architect and lead the implementation of data systems, and data integration solutions for MA Biologics Operations

• Architect and lead the implementation of multiple system integration projects for MA Biologics Operations

• SAIL SO

• PI SME (Vision, AF/EF)

• Strategic deliverables and deliver to results…

• Shopfloor integration

• Process Data Informatics

• Independently leads multi-discipline teams on mega-projects or programs of high complexity

• Conduct customer/project workshops to analyze user requirements and to define functional requirements for process automation solutions through client interviews and documentation analysis

• Develop detailed designs, implements, troubleshoots and test automation and associated system integration solutions that meet client requirements

• Provide functional and project execution leadership and mentors direct reports and project members

• Act internally and externally as an industry-wide expert in automation and information systems

• Accountable for the successful application of technology in the organization and for developing customer relationships. Direct the activities of multiple Lead Engineers, Technical Consultants, or Senior Technical Consultants

• 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 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

• You can perform assignments that have loosely defined goals that require investigation of many variables.

• Can function as 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 cross-functional groups in developing requirements and recommendations for complex automation system modifications.

• Plan schedules and arranges own activities in accomplishing objectives.

• Work is reviewed upon completion for adequacy in meeting goals.

• In addition to working with members of the Site Engineering Group and external Engineering resources, you will have regular contact with Manufacturing and Facility clients.

• You will integrate the Validation and Quality department requirements into the daily routine.

What you bring to Takeda:

• BS degree in an Engineering field (e.g. Computer Engineering, Electrical Engineering)

• 10 years Automation/Operational Technology experience

• Design, and deployment experience with data systems (PI, IP21, Crystal Reports, rtReports) and data integration solutions (OPC, Kepware, Matrikon, LabX, WebAPI)

• Deployment experience with manufacturing/process/plant automation solutions (e.g. DeltaV, ControlLogix)

• Knowledgeable in cGMP

• Experience with SDLC (Waterfall/Agile)

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

• Demonstrate understanding of Windows OS, Networking & System Security Fundamentals and knowledge of S88, S95, MES, ERP, etc.

• Experience with PI Historian, Emerson Inmation, Mettler Toledo LabX

• Background in Automation including SCADA, PLC, OPC, Continuous/Batch Historians and DCS Based control systems (DeltaV, Rockwell, Siemens, iFix).

• Experience with cGMP validation procedures, including generating and implementing validation test protocols.

• Understanding of AF/EF Analytics and SIMCA Software

• Virtualized Server Infrastructure and Networking technologies

• Familiarity with ISA-S88 (standards and terminology for batch control)

• Familiarity with ISA-S95

• Experience with Data Integrity (per FDA and EMA)

• Manage responsibility for large projects

• Manage the automation lifecycle of controls components

• Document and specify control specifications; both new from the ground up, and changes to existing systems.

• Experience with current trends in automation and instrumentation to select and implement modern controls architectures

• Observe domestic and international GMP regulations

• Ability to work with and on computers and monitors for extended periods of time (AI- google it, short and general)

• Work on site at a Takeda location at least three days per week.

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

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training opportunities

• Tuition reimbursement

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. 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 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.

• 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 the best patient support programs. Takeda is a patient-focused company to 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.

This posting excludes Colorado applicants.

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: 100,000 and above.

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