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Project Engineer

Reference:AMC19723 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, Project Engineer

Project Engineer
Contract – 11 months

We’re currently recruiting for an exciting opportunity with a rapidly growing Biopharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

We are looking for:

The ideal candidate would have prior related project engineering experience in a GMP manufacturing facility.

Process and or validation experience in a sterile manufacturing facility would be extremely advantageous.

Education & Experience

  • Previous project engineering experience including project management of change on a commercial site
  • Experienced in process design and equipment
  • Technical transfer experience
  • Experience in Sterile filling processes and equipment (especially aseptic processing)
  • Lean six sigma methodology experience, green belt qualification is a bonus
  • Automation and MES knowledge
  • Audit preparation and execution (desired)
  • Manage multiple projects at 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
  • 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
  • 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
  • Managing vendors for work on site ensuring compliance with safety and permitting requirements for all on site activities.

If interested in this posting please feel free to contact Angela McCauley on +353 (0)87 6930951 or for further information.