Job Description

The role:

PE Global is currently recruiting for a Validation Engineer on behalf of our client based in Carlow. This is an initial 11 month contract role.

The Validation Engineer is responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities.

Responsibilities:

  • Serve as technical and/or validation support as required for manufacturing and new product introduction.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment commissioning and qualification programs
  • Execution of equipment/qualification validation programs; including re-qualification and re-validation
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports,
  • Execution/development of change controls
  • 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.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.

Education and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Would typically have prior related work experience; ideally in manufacturing, preferably GMP Setting
  • Demonstrated technical leadership and delivery of complex cross functional / cross site projects. SME in multiple aspects of aseptic processing.
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job-related computer applications required
  • Lean Six Sigma Methodology experience desired

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