Project Engineer

  • Carlow
  • Careerwise Recruitment
Job DescriptionA Project Engineer is required for a pharmaceutical company based in Carlow. This is an 11-month contracting position. If you have experience in of Sterile filling processes and equipment especially aseptic processing then this is the position for you !!!Role of this position Manage multiple projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects Develop project scope, cost and delivery time schedule for projects, working and collaborating closely with NPI leads to ensure integration into ongoing Validations and/or technical transfers Collaborate closely with cross functional teams to establish scope in improvement projects at Carlow as we ramp up to a fully commercial site Be accountable for equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs. And requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation Drive and support continuous improvement by active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Act as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business JOB REQUIREMENTS Bachelor's degree or higher preferred; ideally in a Science, Engineering or Other Technical Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices In depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing Experience of executing and/or managing through equipment and process design and validation in a sterile environment