Shire Senior Plant Engineer in Cambridge, Massachusetts

Primary Role:

Responsible for the overall performance and monitoring of plant utility systems. Responsible for providing operational and project support for plant utility systems. The operational support will include equipment/system troubleshooting and providing in-house engineering expertise to the maintenance and manufacturing staff.

The primary focus of the position is on GMP/clean utilities and operations (WFI, Purified Water, Clean Steam, Process Gasses, and HVAC systems). A familiarity with non-GMP/plant utilities and operations (Plant Steam, Chilled Water, Electrical and Waste Treatment) is desirable.

Responsibilities include troubleshooting, determining root cause of problems and providing optimization strategies for utility systems within a multi-product, FDA regulated GMP facility. Candidate will be the primary liaison between manufacturing and facilities clients and external engineering contractors and vendors for utility systems. All system improvements will be made in conjunction with manufacturing, facilities, validation, quality assurance and regulatory. Must be able to work in a fast paced multi-disciplinary environment.

Responsibilities:

40%

Operational support

  • Troubleshooting support for complex utility equipment problems as elevated by the plant manufacturing and facilities customer(s)

  • Serves as subject matter expert to support assigned work orders and close out Quality Systems as applicable

  • Serves as subject matter expert for Regulatory filings as applicable

  • On call support 24/7

40%

Small Project Support (cross-site in scope)

  • Accountable for all phases of the Change Control process for owned changes

  • Owns and ensures timely closure of plant equipment and system related CAPAs

  • Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols)

  • Use project management skills to schedule, track progress, and make adjustments

  • Defines all aspects of project scope

  • Uses appropriate business / quality systems such as Trackwise, CMMS, EDC, etc.

  • Knowledge of how small projects tie in to other sites.

  • Provide peer review for all QA and Engineering documentation

20%

Large Project Support

  • Provide project team with utility system engineering design requirements and subject matter expertise

  • Communicate project requirements to vendors to obtain proposals for equipment and system changes

  • Execute JHA/PHA reviews on all new projects/equipment

  • Develop and execute engineering tests, FATs, SATs and commissioning test plans

  • Train operations staff on new/ revised operating procedures

  • Pre/Post approve validation protocols

  • Troubleshoot and remediate exceptions found during IQ/OQ/PQ

  • Support develop engineering project documentation

Education and Experience Requirements:

  • Required education: Bachelors degree in Mechanical or Chemical Engineering

  • Minimum 5-8 years experience with plant utility systems, preferably in a regulated environment

  • Minimum 5+ years experience in equipment design and oversight of fabrication

  • PE license is a plus

  • Knowledge of Quality by Design (QbD), Quality Risk Management (QRM) based on ICH Q8, Q9, and Q10 guidelines and experience with implementing systems following the ASTM E2500 framework is desirable.

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.