Validation Engineer
Reference: SMC19759
Location: Cork
Qualification: Degree
Experience: 3-4 Years
Job Type: Fixed Term Contract
Salary: Not Disclosed
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.
Duties:
* 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.
* Work collaboratively to drive a safe and compliant culture.
Experience and Education:
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* 3-5 years' industry experience.
* Knowledge of CTU equipment qualification, thermal mapping equipment.
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information. #J-18808-Ljbffr