Validation Engineering Lead
6 days ago
Asset Recruitment is a leading provider of contract recruitment services, specializing in pharmaceutical and biotechnology industries. We are currently seeking a highly skilled Senior Validation Engineer for a contract role on behalf of our client, a growing pharmaceutical manufacturer in Ireland.
Job DescriptionThe successful candidate will join the Process Engineering Group on site and report to the Technical Engineering Manager. Primary Responsibilities include:
- Project validation support for equipment performance qualifications (specifically cleaning and sterilization validation);
- Authoring project validation master plans;
- SOP and documentation updates;
- Resolving technical issues encountered during study execution;
- Authoring validation protocols and final reports;
- Executing validation studies;
- Analysis of validation data.
Main Accountabilities
- Design/Author/Review/Approve/Execute development of change controls and qualification/validation of documentation and cycle development studies in line with the standard approval process.
- Serve as validation representative for cross-functional projects and represent the validation team at global technical forums.
- 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.
- Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute cGMP practices in the performance of day-to-day activities and all applicable functions.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections.
- Proactively highlight any issues around compliance.
- Supporting regulatory audits and submissions as required.
- Support continuous improvement through Lean Six Sigma methodologies.
- May be required to perform other duties as assigned.
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