We're currently recruiting for an exciting opportunity with a Biopharmaceutical 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
1. Bring energy, knowledge, innovation to carry out the following:
2. Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
3. Design/Author/Review/Approve/Execute Execution/development of change controls.
4. Resolving technical issues encountered during study execution.
5. Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
6. Technical input into quality notification by authoring/reviewing/approving investigations.
7. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
8. Support continuous improvement through Lean Six Sigma methodologies.
9. Serve as validation representative for cross functional projects and represent the validation team at global technical forums
10. 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.
11. Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
12. Supporting regulatory audits and submissions as required.
Education & Experience
13. Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.
14. Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
15. 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.
16. Exception / Deviation Management and Change Control.
17. Demonstratable experience of leading technical related projects.
18. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
19. Equipment and process validation.
20. Sterile Fill-Finish processes and equipment.
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or sean.mccarthy@lifescience.ie for further information.