Job Description
ref. 01200 Project Process Engineer Exciting opportunity for a Project Engineer with our Carlow based biopharmaceutical client. This is an 11-Month contract role. As Project Engineer you will be responsible for leading multiple Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow. This includes but is not limited to Process improvements, Lean projects and capital projects across multi-disciplined functions which may also require global and network support and collaboration. Responsibilities • Manage multiple projects at Carlow from scope development, design, build/install and qualify through to handover to operations for key Engineering projects at Carlow. • Develop risk-based approaches to investigations and troubleshooting that will feed into future projects using scientific, product and process understanding as a basis for it. • Enhance 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. • Responsible 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. • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. • Active participation in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate for continuous improvement. • Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities. • Act as an intermediary 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. • Work with multiple partners (e.g., Company network groups, third parties, vendors, quality, donor sites, Supply chain, IPT). • Presentations and reporting out on progress of projects to stakeholder as required. • May be required to perform other duties as assigned. Requirements • Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline. • Lean Six Sigma Methodology experience desired; Green Belt preferable. • Considerable experience in a similar role; would typically have experience operating as a senior professional. • Previous engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team through sustaining operations and technical transfer projects. • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. • Thoroughly knowledge and experience of Sterile filling processes and equipment especially aseptic processing. • Proficiency in Microsoft Office and job-related computer applications required. • Experience of executing and/or managing through equipment and process design and validation in a sterile environment. • Automation and MES knowledge. • Experience in audit preparation and execution desired. • Have a proven record of project management of change in a commercial site and process improvement implementation. The suitable candidate will typically have prior related project engineering experience; ideally in manufacturing, preferably GMP Setting with process engineering and/or validation experience in a sterile manufacturing environment. #J-18808-Ljbffr