Posted to MedZilla on 8/20/2019

Takeda Pharmaceuticals

US-MA, Senior Automation Engineer SR0036226-MZ


This individual will be a key player in the conceptual design, detailed design, specification, implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for bio pharmaceutical production and development facilities. Candidate will be the primary liaison between Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of automation systems for cGMP production facilities. All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory. Must be able to work in a fast-paced multi-disciplinary environment.

Operational Support

  • Provides solutions to complex reliability and operational problems.
  • On call to support 24/7 production schedule
  • Owns and ensures timely closure of equipment related quality systems

Control System Support

  • Subject matter expert for the automation system
  • Owns and maintains the design and specifications for equipment and instrumentation
  • Develops automation related SOPs
  • Serves as subject matter expert for quality systems associated with automation systems
  • Evaluates new technologies for their application within a licensed GMP manufacturing facility
  • Maintains control system system & application backups, virus protection, operating system patches, etc.
  • Assists in establishing preventative maintenance requirements and maintaining spare parts support system


  • Specifies and documents requirements
  • Implements requirements following Takeda engineering standard practices
  • Delivers automation design documentation
  • Programs, configures, and integrates new equipment into an existing PCS
  • Develops, reviews, and approves engineering standard practices through collaboration with partner departments Validation, Metro-logy, Facilities, etc.
  • Ensure standards are followed and there is cross-site consistency for both in-house and contractor supported changes
  • Develop commissioning test plans for automation changes

Large Project Support

  • Provides budgetary and schedule estimates for the automation requirements of projects related to new and existing process equipment and control systems
  • Communicate project requirements to vendors to obtain proposals for hardware and software changes
  • Provides project team with automation requirements
  • Provides control system hardware and instrumentation requirements
  • Develops automation project documentation
  • Support process and facilities engineers in equipment commissioning
  • Pre/Post approve control system validation protocols
  • Troubleshoot and re mediate exceptions found during validation
  • Assists process engineers in troubleshooting and remediation of failures
  • Assist in releasing control system for operation

Small Project Support

  • Owns and manages business and quality systems related to project
  • Provides and/or ensures generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
  • Implements automation changes as specified in requirements documents
  • Uses project management skills to schedule, track progress, and make adjustments

Education & Experience Requirements

  • Required education: Bachelors degree in Chemical or Electrical Engineering, or computer Science with appropriate industrial controls experience.
  • Required experience: minimum 5-8 years PLC, SCADA, and instrumentation configuration, programming, and design in a cGMP environment.
  • Desired experience: Siemens PLC Step 7, iFix, iHistorian, OSI-PI, Honeywell DCS, Allen-Bradley PLCs, Delta V, BMS systems, Industrial Ethernet networks, Profibus networks and instrumentation
  • Familiarity with process systems and continuous processes.
  • Maintenance of Site Master Equipment History Files.

Other Requirements

  • Ability to work at all Tekeda MA locations (Cambridge, N Reading, Belmont and Lexington)
  • Expected to carry phone device for on-call 24 hour support as required
  • Travel is currently limited to vendor visits including FAT s and external commissioning. Travel may include international travel
  • Travel should not exceed 20%

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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