Validation Engineer - Process & Cleaning - Biopharm
Our Biotech facility based just outside of Cork is currently investing in their manufacturing programme & is proud to have a high score Glassdoor rating for its working environment!
To be successful for this position we are looking for the following skills & experience
- Process Validation
- 5 yrs in a cGMP environment
- Biopharmaceutical experience
- Experience with Fed Batch equipment such as bioreactors, centrifuge, chromatography columns, UltraFiltration Diafiltration units
- Experience in writing cleaning validation processes
- Provide oversight for validation activities related to the process and cleaning validation activities
- Developing validation plans and rationale for process and cleaning validation studies
- Execute (protocol generation, execution, and final package preparation and reports) validation activities related to process and cleaning.
- Lead and represent Validation in multi-departmental meetings & project teams.
- Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- Identifies and implements improvements to the QA Validation systems
- Participation in the change control program for modifications to qualified processes.
- Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
One of our pharmaceutical clients - a global healthcare leader - is looking for a C&Q Engineer to join their team close to the picturesque and historical city of Cork; which is cementing itself as
One of our pharmaceutical clients - a global healthcare leader - is looking for a Senior Process Engineer to join their team close to the picturesque and historical city of Cork; which is cementing
Republic of Ireland
A fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharma company who focus on a range of products which are life-changing for individuals. We
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