Senior Utilities Project Engineer (cGMP - Pharmaceutical) JD817663
DPS Engineering is looking for a Senior Utilities Engineer to work with a BioPharma client in the Boston, MA area. This candidate will be responsible for overseeing utility system installation; participating in start-up, commissioning and qualification for a new building project. Ideal candidates should have strong experience with clean and plant utility systems including but not limited to WFI, Clean Steam, HVAC, and other related utility systems.
- Participate in equipment submittal reviews to help ensure compliance with Project contract documents.
- Support all commissioning and qualification activities on the project.
- Assist in the generation of a field commissioning and qualification execution schedule to minimize resources required, integrate with construction schedules and maximize system turnover efficiency.
- Develop and peer review commissioning and qualification test protocols and summary reports.
- Work with the Construction Manager to appropriately sequence the turnover of systems to commence commissioning activities, including coordination of the close out of punch list items.
- Coordinate system completion walk-downs.
- Train in qualified document system(s) for document control of qualification protocols, change controls and functional specification documents.
- Support generation of inspection and test plans for equipment, including approach to integrated FATs and leveraging of testing.
- Execute Commissioning and Verification as well as support daily construction activities.
- Coordinate with site engineering department to schedule utility system shutdowns, tie-ins and system startup.
- Help to develop predictive and preventative maintenance program for site utility systems.
- Review turnover packages and ensure that the documentation is accurate and complete and meets specifications.
Skills & Education
- Bachelor's degree in Mechanical or Chemical Engineering or related discipline.
- 12+ years' of relevant experience including similar positions on large capital projects.
- Must have experience with leading mid-to-large capital projects for the pharmaceutical industry.
- Knowledge of production support and building utility systems including, but not limit to, WFI, Clean Steam, Process Gases, HVAC, Plant Steam and Pumped Return Condensate, Process Liquid Waste, Process Chillers, Cooling Towers, and associated operating systems (PLC and BAS/BMS).
- Experience in new facility start-up, large scale equipment package vendor management, and FAT execution and coordination.
- Experience working to regulatory standards: FDA, Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).
- Ability to compile and analyze data.
- Strong organizational skills, oral and written communication and team attitude.
Based on Job Title, Location and Skills
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