Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of accountability and budget responsibility, if applicable.
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.
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.
- Periodically 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, 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 projects
- 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: Bachelor s 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.
- Experience: DeltaV experience is essential. Experience in Allen-Bradley PLCs is very desirable as is Industrial Ethernet networks and Profibus networks. Experience in Siemens PLC Step 7, iFix, iHistorian, OSI-PI, BMS systems and instrumentation is desirable.
- Familiarity with process systems and continuous processes.
- Maintenance of Site Master Equipment History Files.
Key Skills and Competencies
- Strong understanding of Data Integrity (per FDA and EMA)
- 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), ISA88 Batch Control Standard, 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 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.
- 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 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.
- 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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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.