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Details
Validation Engineer
| Reference: | RK26044 | Location: |
Carlow |
| Qualification: | Degree | Experience: | 3-4 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Validation Engineer
Validation Engineer
RK26044
Contract 11 months
Carlow
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical 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.
Key Responsibilities:
- Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
- Design/Author/Review/Approve/Execute Execution/development of change controls.
- Resolving technical issues encountered during study execution.
- Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
- Technical input into quality notification by authoring/reviewing/approving investigations.
- Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
- Support continuous improvement through Lean Six Sigma methodologies.
- Serve as validation representative for cross functional projects and represent the validation team at global technical forums
- 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 actions, participation in audits and inspections and proactively highlighting any issues around compliance
- Supporting regulatory audits and submissions as required.
Education and Experience:
- 3-5 years direct experience with a pharmaceutical or biotechnology company
- Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
- Strong experience in CTU equipment qualification, thermal mapping, equipment/process validation, and sterile fill-finish processes within GMP manufacturing environments.
- Skilled in deviation/change control management, technical project leadership, complex data analysis, and linking equipment performance to out-of-specification findings.
- Knowledge of GMP process monitoring, automation and data systems (e.g. DeltaV, PI System), regulatory/code compliance, and technical report/policy writing.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
Cork City Supply Chain Product Development Engineer Pharmaceutical Sales and Marketing Dublin Quality Control Academic Pharma Sales Engineering Microbiology PhD Validation Engineer Diagnostics Academic Quality Assurance Supply Chain Clinical Research Biopharmaceutical Connected Health Limerick Medical Device Packaging Engineer Allied Healthcare Chemistry Life Science Biotechnology Medical Affairs IT Sales and Marketing Quality Engineering Project Manager Mayo Cork Scientist Scientific Manufacturing Executive Laboratory Scientist
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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