This person will be a key player in the conceptual design, detailed design, specification, implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and development facilities, with a focus on building automation.
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.
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/BMS.
Develops, reviews, and approves engineering standard practices through collaboration with partner departments Validation, Metrology, 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 remediate 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 Mechanical, Chemical or Electrical Engineering, or computer Science with appropriate industrial controls experience.
Required experience: minimum 5-8 years BMS,PLC, SCADA, and instrumentation configuration, programming, and design in a cGMP environment.
Desired experience: Schneider Electric and Johnson Controls BMS systems, Rockwell PLC and SCADA systems, PI Historian, Siemens PLC Step 7, iFix, iHistorian, Industrial Ethernet networks, Profibus and AS-I networks.
Familiarity with facilities, building and HVAC automation principles.
Batch processing understanding preferred.
Key Skills and Competencies
Effective verbal and written communication skills
Able to effectively manage the automation lifecycle of controls components
Ability to effectively document and specify control specifications; both new from the ground up, and changes to existing systems.
Knowledge of IEC 1131 programming languages (structured languages), HVAC Control, and current trends in automation validation
Experience with current trends in automation and instrumentation to be able to select and implement modern controls architectures
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 experience a plus.
Other Job Components
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.
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 group and external Engineering resources, this individual will have regular contact with Manufacturing 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.
List any other job requirements, including domestic travel, international travel, driver s license, physical abilities required, etc.
Ability to work at all Takeda 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%
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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.