Job Description

###

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.###

Key Responsibilities

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.

Experience:

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


###

Skills, Knowledge and Expertise

Highly motivated, pragmatic, and practical individual to support the mission of the CGT Catapult, to assist in the acceleration of the development of a commercial cell-based therapy industry in the UK Desire to establish a high profile career within the cell and gene sector and the personal drive to help push the sector to be a commercial success Understanding of the validation requirements of utility systems, process instrumentation, Biomanufacturing processes, automation (PLC) systems, and analytical equipment Able to evaluate complex situations and determine appropriate solutions in a pragmatic, professional manner Project ownership and pride in its delivery Having a passion for delivering excellent customer service in a cost-effective way Ambitious, collaborative, driven Flexibility towards work assignments and new learning Resilient, with the ability to manage multiple and varied tasks and prioritise workload within a fast-paced environment with accuracy and a strong attention to detail Comfortable operating autonomously once goals and objectives are set Excellent interpersonal, written, and verbal communication and presentation skills Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives Ability to quickly establish credibility and build rapport, respect, and trust A good team player, with strong organisational skills Proven diplomacy skills with diverse groups of internal and external stakeholders A positive attitude towards learning, personal and professional development Keeps up to date with professional knowledge, expertise, and best practice Willingness to travel

Education / Qualifications

A degree in life science / engineering or broad knowledge of the commissioning and qualification of equipment and utilities in a regulated environment
###

About Cell and Gene Therapy Catapult

The Cell and Gene Therapy Catapult (CGT Catapult) is an independent innovation and technology organisation committed to the advancement of cell and gene therapies with a vision of a thriving industry delivering life changing advanced therapies to the world. Its aim is to create powerful collaborations which overcome challenges to the advancement of the sector.

With experts covering all aspects of advanced therapies, it applies its unique capabilities and assets, collaborates with academia, industry and healthcare providers to develop new technology and innovation.

The Cell and Gene Therapy Catapult works with Innovate UK.

CGT Catapult is committed to providing an equal, diverse, and inclusive work environment where everyone's contributions are valued. We celebrate differences, empower, and inspire everyone, because when everyone is included, everyone wins. In 2024, we received bronze accreditation from Inclusive Employers.