This person will be a key player in the implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and development facilities.
Candidate will be the primary liaison between Manufacturing and Facility clients and external engineering and vendor resources in the 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.
- Troubleshooting support for controls and instrumentation
- On call support 24/7
- Serves as subject matter expert to supports timely closure of quality systems associated with automation systems
- Owns and ensures timely closure of equipment related quality systems
- Subject matter expert for the site automation system
- Owns and maintains the design and specifications for equipment and instrumentation
- Evaluate new technologies for their application within a licensed GMP manufacturing facility
- Develops automation related SOPs
- Performs training for users of the systems
- Maintains control system system & application backups, virus protection, operating system patches, etc.
- Assists in establishing preventative maintenance requirements
- Assists in developing and maintaining spare parts support system
- Specification and documentation of client requirements, and implementing requirements in a robust and efficient manner.
- Programming, configuration, and integration of new equipment into an existing PCS
- For projects not implemented in-house ensure all Takeda requirements are rigorously followed
- Provide peer review of code changes
- Develop and execute commissioning test plans for automation changes
Large Projects and Tech Transfer Support
- Provide control system hardware and instrumentation requirements
- Develop automation project documentation
- Support process and facilities engineers in equipment commissioning
- Pre/Post approve control system validation protocols
- Troubleshoot and remediate exceptions found during validation
- Assists process engineers in troubleshooting and remediation of failures
- Assist in releasing control system for operation
- Oversee electrical and controls contractors. Perform I&C wiring as needed
- Owns and manages business and quality systems related to project
- Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
- Implement automation changes as specified in requirements documents
- Use 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 2-5 years PLC, SCADA, and instrumentation configuration, programming, and design in a cGMP environment.
- Minimum 2 years experience in a cGMP Engineering environment
- Desired experience: Siemens PLC Step 7, iFix, iHistorian, Emerson Delta V, Allen-Bradley PLCs, BMS systems, Industrial Ethernet networks, Profibus networks and instrumentation
- Maintenance of Site Master Equipment History Files.
- Ability to work at all Takeda Massachusetts locations (Cambridge 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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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.