- 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 revalidation
- 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.
- Serve as technical engineering representative for internal technical group discussions and represent the site 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 site 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.
- Work collaboratively to drive a safe and compliant culture on site.
- May be required to perform other duties as assigned.
To apply contact Martin Lynch on 087-344 3581.
Email CVs to email@example.com
|Job Category||Validation Engineer|