Senior Validation Engineer
We are seeking a skilled Senior Validation Engineer to join our client based in Co. Carlow in a challenging cGMP environment.
About the Role
* Support Cleaning Validation including Recovery / Cleanability studies.
Your Key Responsibilities
1. Design, author, review, approve and execute qualification/validation documentation and cycle development studies according to standard approval processes.
2. Design, author, review, approve and execute execution/development of change controls.
3. Resolve technical issues encountered during study execution.
4. Engage with Production, Maintenance and Quality representatives in assigned areas of operations during execution of Cycle Development & Performance Qualification activities.
5. Provide technical input into quality notifications by authoring/reviewing/approving investigations.
6. Analyse system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
7. Sustain continuous improvement through Lean Six Sigma methodologies.
8. Represent validation team at global technical forums and serve as validation representative for cross-functional projects.
9. Ensure compliance of Global Policies, Procedures and Guidelines, regulatory requirements and current good manufacturing Practices (cGMP) in day-to-day activities and job functions.
10. Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections.
11. Support regulatory audits and submissions as required.
12. Collaborate to drive a safe and compliant culture.
13. Maintain flexibility to perform other duties as assigned.
Our Requirements
* Experience in cleaning validation including CD & PQ of mobile vessels (CIP) and parts washers (COP).
* Considerable experience in a comparable role in GMP manufacturing settings.
* Relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* Exception/Deviation Management and Change Control expertise.
* Demonstrable 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.
* Continuous professional development is desirable.
* Familiarity with regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
* Ability to analyse and interpret complex data, linking to equipment performance and out of specification findings.
* Report, standards, policy writing skills.
* Equipment and process validation knowledge.
* Proficiency in Microsoft Office and job-related computer applications.
* Excellent communication, presentation, and interpersonal skills.
Desirable Experience
* Filter Validation.
* CCI qualification.
* Shipping Qualification.
* Equipment Periodic Validation.
* Equipment Validation Lifecycle.
* Project Management Skills / Qualification.
* Autoclave / SIP Sterilisation Validation.
* Dry Heat Sterilisation.
* Isolator VHP / HVAC Qualification.
* Controlled Temperature Units / Equipment Qualification.
* Vial and Syringe Processing Technologies.
This is an exciting opportunity to contribute to a dynamic team and enhance your career in a challenging cGMP environment.