Project Engineer

Contract
Leinster
Posted 1 year ago

Reporting to the Associate Director Technical Engineering as Project Engineer you will lead and manage multiple Technical Engineering projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects on site. This includes: Process improvements, capital projects and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. You will have prior related work project engineering experience; ideally in manufacturing, preferably GMP Setting with process engineering and/or validation experience in a sterile manufacturing environment. Proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation

 

 

Responsibilities

 

  • Manage projects on site from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects on site.
  • 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
  • Collaborating closely with cross functional teams to establish scope in improvement projects at site as we ramp up to a fully commercial site
  • 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
  • Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making)
  • 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 e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system Integration of Computer Systems Validation activities, in collaboration with Automation/IT partners, into required projects
  • 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
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance

 

Qualifications & Education

 

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
  • Green Belt preferable
  • Experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business
  • Would have 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
  • Experience in leading through change would be an advantage
  • Knowledge of regulatory/code requirements to Irish, European and International
  • 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
  • Good shipping/Filter/Cleaning validation knowledge required
  • Knowledge of QbD/CPV desirable
  • Excellent report, standards, policy writing skills required
  • Automation and MES knowledge
  • Proficiency in Microsoft Office and job-related computer applications required
  • Lean Six Sigma Methodology experience desired
  • Experience in audit preparation and execution desired
  • Proven record in planning and basic project management of a team to deliver on time/schedule and cost
  • Proven contractor and vendor management
  • Demonstrate analytical and systematic problem-solving skills
  • Effective time management and multi-tasking skills
  • Trouble shooting skills
  • Goal/results orientated
  • Excellent attention to detail
  • Self-motivated
  • Flexible approach
  • Have shown the ability to manage budgets and forecasts and use a formal capital management process

 

To apply contact Martin Lynch on 087-344 3581.

 

Email CVs to mlynch@mile.ie

Job Features

Job CategoryProject Engineer

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