Ref. 01209
CLEAN UTILITIES LEAD ENGINEER
We are seeking a Clean Utilities Lead Engineer for a project management team for a Biologics manufacture facility in Dublin. Reporting to the project manager, manage all the design and build of utilities related facility projects. Provide day to day support and coordination during the full cycle of design, build, and C&Q of clean utilities.
Responsibilities
The utilities engineer will be responsible for the full life cycle of the project from concept to completion:
• Lead design, build, commissioning and qualification of clean utilities systems to ensure that cGMP and related regulations are being followed.
• Provide calculations, systems design and layout, perform load calculations and select equipment to ensure proper design, build and C&Q of utilities / facility equipment/systems.
• Develop and lead reviewing engineering documents for equipment, Facility and utilities and support Project Execution, Vendor Development, including URS, FS, DQ, FAT, FAT, IQ, OQ, and PQ documents.
• Lead commissioning and qualification activities.
• Coordinates all aspects of project document completion within the organisation, externally with vendors, and with other relevant design professionals.
• Support daily construction and project related activity.
• Coordinate with sub-ordinates, consultants, engineering firm and general contractors
Requirements
• 10+ years of proven engineering experience with at least 8 years within the pharmaceutical, biotech, life sciences industries or engineering firm is required.
• Chartered Engineer license in mechanical services.
• BSc degree in Mechanical or Process Engineering.
• 10+ years of experience in Clean utilities design and operation experience.
• Good time management skills and ability to work in fast-paced environment.
• Hands-on experience in systems of clean and black utilities, including purified water, water for injection, clean steam, compressed process air and special gases.
• Be familiar with safety rules and regulations as per national and other applicable agencies, such as FDA, EMA and HPR.
• Strong operation knowledge of building automaton system (BAS), facility monitoring system (FMS) and computerized maintenance management system (CMMS).
• Strong project management skills with Good Communications Skills.
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