Validation Specialist

Description

To drive the completion of validation activities associated across the CGT Catapult’s Manufacturing Innovation Centres (Equipment / Facilities / Utilities / Laboratory Systems). The role will require support of both our Manufacturing Innovation Centres in Stevenage and Braintree. The Validation Specialist function will work across the following areas:

• Critical Systems / Utilities / Equipment
• Cleaning
• Laboratory Equipment
• Computerised Systems
• HVAC

As part of the above, this role is responsible for authoring, executing and reporting validation activities within the framework of cGMP - Annex 11 & 15 and in compliance with the CGT Catapult’s QMS requirements. The Validation Specialist will be required to support multiple validation projects, liaising with the project teams, SMEs and all associated departments on site relating to the validation objectives and ensuring that work is completed accurately and in a timely manner.

On occasion, the Validation Specialist may be required to travel within the UK and internationally to attend meetings and perform activities.

Validation/Technical:

• Maintain up-to-date industry best practice knowledge of validation trends
• Supervise validation exercises performed by third parties to ensure work is completed following Data Integrity requirements (ALCOA Standards)
• Work with vendors to resolve issues and ensure complete deviation reporting investigation and closure for validation activities
• Assist in the authoring of User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols / reports for validation activities
• Drive validation project completion (DQ/IQ/OQ/PQ) in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved, ensuring when appropriate that Quality by Design (QbD) principles are always incorporated into all validation design activities
• Ensure the implementation of a risk-based approach to the validation of systems including computerised systems in accordance with EU GMP Annex 11, 15 and GAMP 5, whilst ensuring compliance with the company QMS
• Attend design meetings, and factory acceptance tests at vendor sites
• Identify, develop, and maintain good stakeholder relationships
• Ensure adequate training in appropriate procedures and principles for all employees undertaking any aspects of validation during any stage(s) of validation activities
• Ensure adherence to the Company’s Change Management System for all changes to existing or implementation of new systems or processes
• Promote and implement continuous improvement initiatives to ensure the smooth operation of the validation department

Non-Technical:

• Work within the CGT Catapult MIC’s multi-disciplinary team and matrix environment to ensure successful delivery of CGT Catapult projects
• Establish links with outside parties to benefit the CGT Catapult MIC’s Validation processes including identifying and evaluating new technologies where appropriate
• Pursue a programme of continuous professional development in accordance with any relevant professional registration or statutory requirements
• Work in a safe manner and in compliance with all health, safety, and environment mandatory policies, standards and procedures

The above is only an outline of the tasks, responsibilities and outcomes required of the role; undertake other duties as may reasonably be required as the CGT Catapult MICs evolve under the dynamic CGT Catapult business strategy.

• Possess a wide range of validation in a GMP environment experience and knowledge to facilitate a pragmatic and novel approach to different validation requirements, including Computer Systems Validation
• GMP experience in Biopharmaceutical products with significant Validation experience, or a combination of Validation and Engineering/Commissioning experience
• Experience of collaborating successfully with a team of validation engineers, SMEs, specialists, and a network of external contracted resources
• Experience in direct interaction with the regulatory authorities
• Experience in direct interaction with clients and collaborators

• Highly motivated, pragmatic,…