Headcount Solutions is sourcing Project Engineers for a leading multinational client in Leinster. These engineers will lead and manage multiple technical engineering projects from scope development, design, build/install and qualify through to handover to operations. This includes but is not limited to: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration
· 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 all Tech. Eng. projects, working and collaborating closely with Technical Engineering Leads to ensure integration into ongoing
Validations and/or Technical transfers
· Act as a subject matter expert on: 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.
· Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues; implement subsequent corrective action.
· Drive collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant
· 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
· Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
· Process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects
· Ideally possess 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
· Good shipping/filter/cleaning validation knowledge required
· Knowledge of QbD/CPV desirable