Validation Manager

ROLE OVERVIEW

This is an exciting opportunity for a Validation Manager to join a growing pharmaceutical manufacturing organisation . Our client is seeking an experienced validation professional to lead and develop a high-performing Validation team responsible for ensuring the compliant validation of facilities, equipment, systems and processes operating within a GMP-regulated environment.

The successful candidate will play a critical role in supporting the organisation's ongoing cGMP compliance strategy by driving validation excellence, continuous improvement and regulatory readiness. This position offers the opportunity to provide technical leadership across validation activities, whilst working closely with Quality, Engineering and Operations teams to ensure compliance with EudraLex Volume 4, including Annex 11 and Annex 15 requirements.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Validation Manager will be varied, however the key duties and responsibilities are as follows:

1. Coordinate and perform validation project activities for facilities, equipment, systems and processes in compliance with EudraLex Volume 4 GMP requirements and other applicable quality standards.
2. Lead, develop and mentor the Validation team whilst supporting the recruitment, training and performance management of team members.
3. Establish and maintain validation procedures, policies, Validation Master Plans (VMPs), SOPs and departmental best practices to ensure ongoing compliance and operational effectiveness.
4. Prepare, execute and review validation protocols and reports, ensuring all activities are completed in line with regulatory and company requirements.
5. Liaise closely with Engineering, Quality Assurance and User Departments to ensure validation activities are delivered efficiently with minimal disruption to operations and production schedules.
6. Drive continuous improvement initiatives by reviewing and rationalising validation documentation, processes and protocol requirements whilst maintaining full regulatory compliance.
7. Maintain awareness of regulatory developments and industry best practice, representing the Validation function during internal meetings, customer audits and regulatory inspections.
8. Ensure validation procedures, policies, master plans and supporting documentation are reviewed, updated and maintained in line with evolving regulatory expectations.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Validation Manager we are looking to identify the following on your profile and past history:

1. A degree-level qualification in Chemistry, Biology, Engineering or a related scientific discipline.
2. A minimum of 10 years' experience working within Validation and GMP-regulated pharmaceutical manufacturing environments.
3. Proven experience leading, managing and developing validation teams.
4. Strong knowledge of EudraLex Volume 4, including validation requirements contained within Annex 11 and Annex 15.
5. Demonstrable experience authoring and executing validation protocols, validation reports, procedures and Validation Master Plans (VMPs).
6. Experience managing facility, equipment, process and computerised system validation activities within a regulated GMP environment.
7. Excellent communication, stakeholder management and organisational skills, with the ability to work independently and collaboratively across multiple departments.

WHAT'S IN IT FOR YOU?

1. Opportunity to play a key role in supporting the organisation's cGMP compliance and quality objectives.
2. Leadership position with responsibility for building, developing and mentoring a talented Validation team.
3. Exposure to a broad range of validation projects across facilities, equipment, systems and manufacturing processes.
4. Collaborative working environment with strong cross-functional engagement across Quality, Engineering and Operations functions.
5. Competitive salary, benefits package and ongoing career development opportunities.

Key Words: Validation Manager / Pharmaceutical Manufacturing / GMP Compliance / cGMP / EudraLex Volume 4 / Annex 11 / Annex 15 / Validation Master Plan / VMP / Equipment Validation / Process Validation / Facility Qualification / Computer System Validation / Quality Assurance / Regulatory Compliance / Team Leadership / Continuous Improvement