Validation Lead

To govern and oversee the overall site validation strategy and perform validation activities associated with the CGT Catapult Stevenage & Braintree sites (equipment/facilities/utilities/laboratory systems/computerised systems). The Validation Lead will work across the following areas:

• Maintenance of all validation across the CGT Catapult Stevenage site, including Facility, Utilities, equipment, process, cleaning, sanitisation, sterilisation, transport, and computerised systems.
• Establishing the qualification strategy for all validation activities.
• Periodic review and requalification.
• Management of planned and unplanned change (Change Control & Deviations) as they impact qualification status.

As part of the above, the Validation Lead is responsible for authoring, executing, and reporting validation activities within the framework of cGMP - Annex 11 & 15 and in compliance with the CGT Catapult PQS requirements and is expected to represent Validation during internal and external audits and inspections (by both regulatory authorities and collaborator organisations). The Validation Lead will be required to manage multiple validation projects, liaising with the project teams and all associated departments on site relating to the validation objects and ensuring work is completed in line.

Key Accountabilities:

Validation/Technical:

• Lead validation activities including defining the validation requirements to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP.
• Translate local and regulatory requirements into a validation strategy for the site.
• Manage third party contractors to support commissioning, start-up, and qualification activities.
• Maintain technical independence and up-to-date knowledge of validation standards and regulatory compliance requirements and independently contribute to development of new site validation standards.
• Ensure validation testing performed by vendors is complete and accurate, work with vendors for issue resolution and validation deviation reporting.
• Perform Risk Assessments, such as Failure Mode Effect Analysis (FMEA) for example, to critique a utility or equipment and thereby define the level and scope of validation required.
• Write User Requirement Specifications, Design/Installation/Operational/ Performance Qualification protocols and reports for validation purposes.
• Run validation project execution DQ/IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved.
• Proactively coordinate validation activities and act as a central point of contact for validation to ensure requirements are delivered on schedule.
• Be involved in the Implementation of a risk-based approach to the validation of systems in accordance with EU GMP Annex 11, 15 and GAMP 5, along with company PQS and applicable guidelines.
• Represent the Validation function during audits and inspections.
• Attend design meetings, and factory acceptance tests at vendor sites as required.
• Plan and prioritise the resource workload to ensure that agreed deadlines are met. This includes coordinating and performing validation activities, tracking, and reporting the progress of activities, anticipating, and removing obstacles to progress.
• Identify, develop, and maintain stakeholder relationships.
• Provide periodic updates to the Head of Validation, Managing Director of Quality, Executive Management Team, and other stake holders.
• Train employees in validation procedures and principles during execution activities.
• Adhere to the company Change Management System for all changes to existing or implementation of new systems.

Management:

• Manage the relationship with all commissioning, qualification, and validation service providers. Monitor KPIs to ensure performance is maintained and CGT Catapult value for money is achieved.
• Lead the CGT Catapult Stevenage Validation team including recruitment, selection, motivation, training, appraisals, and management of staff performance.
• Work within the CGT Catapult Stevenage multi-disciplinary team and matrix environment to ensure successful delivery of CGT Catapult/Collaborator projects. Liaise with Collaborators and other CGT Catapult teams to ensure resources are used efficiently & effectively.
• Establish links with outside parties to benefit the CGT Catapult Stevenage Validation processes including identifying, evaluating & adapting new technologies and methodologies where appropriate.
• Provide reports through data analysis using software to meet validation schedule targets and lead on the preparation of any required presentations.
• Personal development – Pursue a programme of continuous personnel development in accordance with any relevant professional registration or statutory requirements.
• Travel within the UK and internationally to attend meetings and perform activities when required.
• Work in a safe manner and in compliance with all Health, Safety & 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 by CGT Catapult.

Experience:

• Minimum of 5 years Validation experience in an aseptic pharmaceutical or biopharmaceutical manufacturing environment. A combination of Validation and Engineering/Commissioning experience would be advantageous.
• Experience of managing a team of validation engineers, specialist, and a network of external contracted resources.
• Experience of successful interfacing with Facilities, Quality, Operations, and Information Technology groups to develop requirements, establish programs and manage day-to-day operation.
• Understanding of utility systems, process instrumentation, automation systems, and analytical equipment.
• Experience of maintaining and enhancing overarching, comprehensive and compliant life-cycle programs for validation of facility environments, utilities, and systems.
• Experience of establishing function-appropriate qualification programs for laboratories (Development and Quality Control).
• Experience of leading or assisting in recruiting and selecting new staff.
• Experience in interacting with the regulatory authorities.
• Experience in interacting with clients and Collaborators.

Knowledge / Skills / Competencies:

• Highly motivated, pragmatic, and practical to support the mission of the Cell and Gene Therapy Catapult to assist in the acceleration of the development of a commercial cell-based therapy industry in the UK.
• Highly methodical and organised, including time-management skills and changing priorities
• Able to evaluate complex situations and find solutions for them in a professional manner.
• Curious and eager to learn with strong ability for analytical problem solving.
• Able to take initiative and work independently; sense of urgency in completing assigned tasks
• Project ownership and pride in its delivery.
• Having a passion for delivering excellent customer service in a cost-effective way.
• A good team player, with strong organisational skills.
• Flexibility towards work assignments and new learning.
• Ambitious, collaborative, driven.
• Ability to manage multiple and varied tasks and prioritise workload with attention to detail.
• Resilience, and ability to work well under pressure.
• Ability to work both reactively and pro-actively.
• Comfortable operating autonomously once goals and objectives are set.
• Excellent interpersonal, written, and verbal communication skills.
• Accurate with a strong focus on attention to detail.
• Having current and up to date professional knowledge, expertise, and best practice.
• Proven ability to engage constructively with colleagues at all levels across different departments to deliver objectives and to respond to a wide range of customer and management needs.
• Ability to quickly establish credibility and build rapport and trust.
• 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:

• BS or MS degree in life science or engineering discipline; knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP/EA/MHRA policies/guidelines).