Our Client, based in Carlow is looking for a Validation Engineer who will be responsible for providing process, technical, and validation support to 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. Co-ordination, design and execution of equipment qualification and validation as required.
- 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 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.
- Serve as technical engineering representative for internal technical group discussions and represent the company at global technical forums.
- Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
- Drive compliance of 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.
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
- 5 years' experience in a similar validation role.
- 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.
Tandem Project Management