Validation Manager

Our Home Counties Based partner is enjoying a period of significant investment on its site, including brand new production lines and new equipment to upgrade old facilities, to maintain quality whilst increasing site productivity.

THE ROLE:

- The Interim Validation Manager will be required for an initial 6 month contract, to be responsible for the management of the validation team, for both operational revalidation and new project/equipment validation.
- They will have a team of 6-12 people to manage and ensure that site validation is carried out in line with the site master validation plan.
- The team are currently involved in a broad range of operational and capex work across a broad range of process equipment within a highly regulated Biopharmaceutical manufacturing environment during a significant period of projects and investment.

KEY RESPONSIBILITIES:

- To Project Manage process validation activities within a highly regulated biopharmaceutical manufacturing environment; specific focus will be on Downstream - Filtration/Ultrafiltration processing and aseptic fill finish work.
- Planning and organising resources in line with the site requirements
- Co-ordinate with other groups with responsibilities for process/cleaning validation activities directly related to validation, eg Project Engineering.
- Provide up to date information to Line Management on activities and time lines relating to validation work, utilising appropriate techniques.
- Write and review process validation protocols and reports for new and existing equipment - taking responsibility for the accuracy of the departments reports
- Review/produce supporting validation documentation, as required, as part of a validation exercise.
- Provide technical support to the team on technical queries