Purpose Owns projects, equipment, responsible for document drafting and protocol execution Clean Utilities/ Facilities / Equipment Commissioning and Qualification (C&Q) engineer for a capital project. Ensure the C&Q activities associated with the capital project are completed safely, as per schedule and in compliance with GMP and QualityRequirements. ResponsibilitiesCommissioning & Qualification of Clean Utility Systems / Facility and Process equipment.Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary ReportProvide technical assistance during investigations and system design.Coordinates and Supervises all C&Q activities on their systems.Ensures the C&Q schedule is maintained.Manages Daily C&Q coordination meetings.Responsible for Tracking and Reporting of C&Q status and risks/issues.Ensures Startup of equipment/utilities is completed in a safe and coordinated manner.Assist in the development of User Requirement Specifications (URS's) and QualityRisk Assessment for Equipment and Automated Systems (QRAES).Qualifications3+ years experience in Engineering or Commissioning and Qualification ManagementTechnical qualification at third level or equivalent in Engineering.Extensive knowledge and demonstrated experience managing Commissioning andQualification for Pharmaceutical / Biotechnology projects preferredKnowledge of safety, GMP and environmental regulatory requirements.Demonstrated strong Communication and Leadership skills.Demonstrated ability to collaborate with senior stakeholders to achieve optimaloutcomes.Strong understanding of a risk based approach to commissioning and qualificationwithin the biotechnology industryFamiliarity with paperless validation systems.