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.
The candidate must have the rights to work in the location stated in the job advert.
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