Validation Technologist - BioPharma
The purpose of this role is to take the lead to execute and manage validation activities relating to Process and Cleaning validation.
This will involve coordination with Engineering, Production, QC and QA departments to ensure a timely delivery of the qualification report.
The post holder may be expected to supervise contractor resource where appropriate with responsibility to ensure adequate training and supervision is provided.
The post holder will be required to write, review and where appropriate approve validation reports prior to execution, followed by report generation.
In addition to Cleaning and Process validation activities the post holder will be expected to undertake any related validation activities deemed necessary by line management. This could include the generation of validation documentation in accordance with the full validation life cycle for equipment, utilities and facilities.
- Manage, execute and deliver Cleaning and Process Validation projects according to the business priorities and project time-lines.
- Design and optimise Cleaning -in-place processes.
- Writing, reviewing and approving validation protocols.
- Be able to work alone or within a matrix team structure.
- Follow up and resolve discrepancies, CAPAs and non-conformances.
- In lines with overall responsibilities, perform additional tasks assigned by the Line - manager.
- Undertake all work in accordance with local safety and security procedures.
Previous knowledge of GMP Biopharma processes and / OR Validation life cycle documentation.
General education to BTEC National Certificate or equivalent, including science
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- Quality Control
- Cleaning Validation