This is an exciting opportunity for an Engineering Specialist (Validation) interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation.
Key Roles & Responsibilities
- 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.
- Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance.
Experience
- Knowledge of CTU equipment qualification
- Knowledge of thermal mapping equipment
- 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
- Equipment and process validation.
- Sterile Fill-Finish processes and equipment.
Education
Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108