JOB OFFER

JOB DETAILS

Title:
Equipment Project Engineer
Location:
Galway
Job Type:
Galway

Equipment Project Engineer

Equipment Project Engineer

GerTEK Project Management & Technical Services is one of Ireland’s leading Project Management and Technical Service companies. Due to continued expansion, we are hiring for an experienced Equipment Project Engineer to join our team.

As an Equipment project engineer you will liaise with the engineering team working on Automation and Equipment Projects.

Job Responsibilities

  • Manage projects from scope development, design, build/install and qualify through to handover to operations
  • 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 Eng projects, working and collaborating closely with Technical engineering leads to ensure integration into ongoing Validations and/or Technical projects
  • Collaborate closely with cross functional teams to establish scope in improvement projects
  • 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
  • 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
  • Collaborate with multiple partners in achieving excellence in technical transfer programmes. Serve as technical engineering representative for internal technical group discussions

Qualifications

  • Bachelor Degree or higher preferred; ideally in a Science, Engineering or Other Technical discipline
  • Project management Qualification (PMP) desirable

Key Requirements

  • 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
  • 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
  • Having a strong safety experience
  • Have proven record of process improvement implementation
  • Have a proven record of project management of change in a commercial site
  • Have shown the ability to manage budgets and forecasts and use a formal capital management process

Job Types: Full-time, Contract, Permanent

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