Job Description
Purpose The Utility Project Engineer is responsible for ensuring that all utility/infrastructure systems perform predictably and continue to operate as required in order to support the manufacturing process. The Facilities Engineer also ensures that all utility systems, GMP and non-GMP, conform to relevant regulatory requirements as well as company specifications and requirements. The incumbent will also support Manufacturing in the implementation of process improvements and enhancements. This includes design, scope definition, change control and project management. Responsibilities Responsible for projects, vendor inquires and troubleshooting of process and utilities systems. Participate on capital project teams through all phases of projects; these phases will include conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification. Responsible for initiation and completion of deviations, CAPAs, and change controls for process and utility systems Provide support to manufacturing and maintenance where required. Provide on-call support during project and shutdown activities, as required. Creation of preventative maintenance plan and identification of conditioned based maintenance strategies suitable for sustained operations. Project budget oversight of multiple projects. Lead FMEAs and identify critical spare parts. Ensure that new equipment is included in the plant maintenance and calibration program. Plans and manages critical tie in during shutdown activities. Oversees process and utility system upgrades Performs investigations relating to equipment malfunctions. Other duties as required. Requirements 5-8 years relevant experience in a cGMP commercial manufacturing environment Experience in troubleshooting and providing technical support for cGMP manufacturing, equipment, utilities, and HVAC systems in a biological or aseptic processing environment Experience with sanitary design of piping and manufacturing equipment Ability to read and understand sophisticated architectural, equipment and system drawings. Knowledge of GMP utility systems (i.e. CIP, SIP, WFI, clean steam, pharmaceutical gas systems). Experience in working with equipment manufacturers and developing preventative maintenance procedures for cGMP manufacturing equipment Skills: GMP Utility Systems PM Procedures