Process Project Engineer

  • Contract
  • Calrlow

Website TPM05467

An exciting opportunity has arisen for a Project Engineer with our Carlow based biopharmaceutical client. The successful candidate will lead and manage multiple engineering projects from scope development, design, build/install and qualify through to handover to operations for key engineering projects on site. 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. The suitable person 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


  • Manage multiple projects on site from scope development, design, build/install and qualify through to handover to operations for key engineering projects.
  • 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 on site as they 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.
  • Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Presentations and reporting out on progress of projects to stakeholder as required.
  • Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.

Qualifications & Experience:

  • Bachelor’s degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline.
  • Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business.
  • 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.
  • Have a proven record of project management of change in a commercial site and process improvement implementation.
  • Experience in leading through change would be an advantage.
  • Experience of executing and/or managing through equipment and process design and validation in a sterile environment.
  • Experience in audit preparation and execution desired.
  • Green Belt preferable.
  • 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.
  • 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.

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