Shire Sr Automation Engineer in Lexington, Massachusetts

Primary Role:

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.

Responsibilities:

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

Programming

  • Specifies and documents requirements

  • Implements requirements following Shire 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.

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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.

Other Requirements

List any other job requirements, including domestic travel, international travel, driver’s license, physical abilities required, etc.

  • Ability to work at all Shire 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’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire 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 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 is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, 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 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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.