The Opportunity
The Engineering Validation Manager has responsibility for leading and directing all equipment requalification and specific initial qualification activities across the Runcorn site. This role plays a critical part in maintaining regulatory compliance and operational excellence. The position develops and directs a team of validation professionals and is accountable for strategic planning, scheduling and execution of validation activities with key cross-functional stakeholders. A strong emphasis is placed on planning, execution, and building a capable, responsive, and future-ready team.How You'll Spend Your Day
Functional Leadership & Team Development• Lead and develop a high-performing, multi-disciplinary team with the goal to maintain the validated state of equipment across site.• Define training and development frameworks, including capability matrices, coaching plans, and individualized development pathways.• Drive technical excellence and succession planning through structured assessments and ongoing mentoring.• Ensure training records and technical competencies are current across all team members.
Training and development• Continuously develop in-depth knowledge of the relevant regulations, industry standards and technical requirements. Improve skills and know how in validation / qualification. Actively engage with industry forums and ensure knowledge is up to date as regulations or recommended practices change. • Identification of key skill sets required for the validation team roles and ensuring that each team member is well-equipped to perform their tasks with confidence.• Develop and deploy training plans, mentoring and coaching technicians as required. Supporting each team member with their own personal development plan as it relates to technical ability.
Strategic Validation Oversight• Provide strategic oversight and in depth understanding of temperature mapping and smoke visualisation qualification activities including equipment, utilities, and controlled environments across the site. • Input into the site Validation Master Plan (VMP), ensuring alignment with global Teva standards, cGMP, and regulatory expectations.• Provide final approval on validation protocols and reports across equipment, utilities and controlled environments.• Lead planning and execution of Annual, Quarterly, and Monthly validation and requalification schedules across all system types.• Ensure a risk-based approach to validation activities, embedding industry best practices and emerging regulatory guidance.• Accountable for the development and maintenance of site validation templates, ensuring alignment with corporate standards and best practices.• Drive data-driven validation planning through risk assessments, performance trends, and periodic review findings.
Engineering
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