We are seeking a highly skilled Clean Utilities Project Manager to lead our project management team for a Biologics manufacture facility in Dublin. The successful candidate will be responsible for managing all design and build of utilities related facility projects.
Responsibilities
* Lead design, build, commissioning and qualification of clean utilities systems to ensure compliance with cGMP and related regulations.
* 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 review engineering documents for equipment, Facility and utilities and support Project Execution, Vendor Development, including URS, FS, DQ, FAT, IQ, OQ, and PQ documents.
* Lead commissioning and qualification activities.
* C coordinate all aspects of project document completion within the organisation, externally with vendors, and with other relevant design professionals.
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.
* Familiar with safety rules and regulations as per national and other applicable agencies, such as FDA, EMA and HPR.
* Strong operation knowledge of building automation system (BAS), facility monitoring system (FMS) and computerized maintenance management system (CMMS).
* Strong project management skills with Good Communications Skills.