We are currently working with an established business based in Porton Down Science Park who are looking to recruit a Process Validation Lead.
You will be joining the Process Validation team within the Validation Department, who are responsible for the execution of Performance Qualification and Process Performance Qualification activities in support of manufacturing activities and in accordance with regulatory requirements.
As a Process Validation Lead, you will be expected to attend project group meetings, liaise with other support teams, regulatory bodies, and peers to establish data for inclusion into protocols and reports.
Main responsibilities include:
Coordinate the execution of the Validation Master Plan with respect to Process Validation activities.
Assess Change Control documentation to determine change impact with respect to the validation requirements and report appropriately.
Support operational areas in the implementation of change.
Lead Process Validation activities.
Define Process Validation Strategies.
Author, review and approve where appropriate Process Validation plans, protocols and reports ensuring compliance to policies and procedures as required.
Approve Process Validation plans, protocols and reports ensuring compliance to policies and procedures as required.
Schedule and support Process Validation executions.
High level of technical and scientific writing required.
Understand and apply statistical tools for development of protocols and data analysis for Process Validation (as per current FDA/MHRA Process validation lifecycle guidelines).
Lead Continued Process Verification activities including the generation of CPV plans and reporting.
Present Process Validation documents at regulatory audits.
Performs process investigations with relevant departments as required.
Performs product and process impact assessments.
Participates in or leads process and quality risk assessments.
Presents findings at group and at interdepartmental meetings.
Communicate information on current process data which may impact Process Validation.
Maintain and review the Product Control Strategy for all products. Understand the functional relationships that link CMA/CPP/PP to CQA.
Ensure the timely completion of Deviations and the closure of CAPAs.
Coordinate Contractor or permanent resources to deliver timely documentation in support of Process Validation activities.
Person Specification:
Have current right to work in the UK.
Degree in Science or Engineering or equivalent and recognised academic achievement.
Minimum of 10 years validation experience ideally within a Biopharma environment.
Biotechnology experience.
Statistical evaluation of data.
Understanding of the Validation Life Cycle.
Project Management experience.
Management of internal customer expectations.
Statistical package use.
Good computer skills: Word, Excel.
Coordination of cross functional teams.
For more information, please contact Carrie today!