Alexion Pharmaceuticals Utilities Engineer in Ireland
The Utilities Engineer is responsible for ensuring that all facility utility/infrastructure systems perform predictably and continue to operate as required in order to support the manufacturing process. The Utilities 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.
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
Act as SME for internal and external inspections
Act as system owner on utility systems
Provide support to manufacturing and maintenance where required.
Provide on-call support during project and shutdown activities, as required.
Ensure completion of preventative maintenance and capital improvement activities in accordance with shut down plan.
Ensure that new equipment is included in the plant maintenance and calibration program.
Plans and manages maintenance shutdown activities.
Oversees process and utility system upgrades
Performs investigations relating to equipment malfunctions.
Other duties as required.
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
- BS in chemical or mechanical engineering plus 5-8 years relevant experience in a cGMP commercial manufacturing environment or MS in chemical or mechanical engineering plus 2-5 years relevant experience in a cGMP commercial manufacturing environment.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.