Our client based in Carlow has an exciting opportunity for an Engineering Specialist (Validation) interested in a new challenge in a cGMP regulatory environment. The successful candidate will support several aspects of Validation predominantly Isolator and Filling Line qualification and studies.
- 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.
Qualifications & Experience:
- Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
- Knowledge of HVAC systems.
- Knowledge of Isolator VHP qualification.
- Knowledge of Sterilisation processes for Isolators.
- Thermal mapping skills.
- Exception / Deviation Management and Change Control.
- Demonstratable experience of leading technical related projects.
- Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
- Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
- Report, standards, policy writing skills required.
- Equipment and process validation.
- Sterile Fill-Finish processes and equipment.
- Proficiency in Microsoft Office and job-related computer applications required.
To apply for this job email your details to firstname.lastname@example.org.