Validation Engineer/Autoclave load validation engineer
Posted on Apr 6, 2022 by Michael Bailey Associates - UK Contracts
A Pharma company in Switzerland is looking for a Validation Engineer/Autoclave load validation engineer to join their Late-Stage development department. If you are interested and want to know more details, send and application and we'll be in touch!
In this role, you will be responsible for Validation activities for (new) biopharmaceutical processes in the Late-Stage Development department. Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
- Define strategy, plan, coordinate and execute all phases for performance qualification of process equipment.
- Define strategy, plan, coordinate and execute all phases for supporting validation activities such as autoclave load validation, sterilization in place validation or temperature mapping validation studies.
- Bridging with cross-functional teams handling and ensuring equipment and process readiness for production
- Create, review and approve technical and GMP related documentation.
- Supporting engineering, quality, quality control and production in a campus-wide validation team.
- Coordination and oversight of external validation partners.
- Analytical thinking and problem-solving ability
- Basic Know-how of biotechnology processes
- University degree in natural or technical sciences or equivalent by experience
- Work experience within a pharma or a biotech company
- Know-how of Qualification/Validation requirements according to cGMP is a major plus.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.