Shire Senior Plant Engineer in Cambridge, Massachusetts
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.
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
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
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.
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