Process Validation Specialist

Introduction to role

The successful candidate 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 PBL manufacturing activities and in accordance with Regulatory requirements.

As a Process Validation Specialist for Porton Biopharma, the post holder will be expected to attend project group meetings, liaise with PBL support teams, regulatory bodies and peers to establish data for inclusion in protocols and reports.

Key Responsibilities

• To 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.
• To support operational areas in the implementation of change.
• Support Process Validation activities.
• Define Process Validation Strategies in conjunction with the Process Validation Lead.
• Author and review Process Validation plans, protocols and reports ensuring compliance to PBL policies and procedures.
• Schedule and support Process Validation executions.
• High level of technical and scientific writing required.
• Understand and Applies statistical tools for development of protocols and data analysis for Process Validation (as per current FDA/MHRA Process validation lifecycle guidelines). Participate in Continued Process Verification Activities (CPV) including the generation of CPV plans and CPV 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 Lead 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 to CQA.
• To ensure the timely completion of Deviations and the closure of CAPAs.

Personal Specification

• Have current right to work in the UK;
• Degree in Science or Engineering or equivalent and recognised academic achievement.
• Understanding of the Validation Life Cycle.
• Project Management experience.
• Management of internal customer expectations.
• Statistical package use.
• Good computer skills: Word, Excel.
• Validation experience ideally within a Biopharmaceutical environment.
• Biotechnology experience.
• Statistical evaluation of data.
• Coordination of cross functional teams.