Engineering Validation Manager in Harlow

Who We Are

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us. We’re Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.

The Opportunity

The Engineering Validation Manager has responsibility for leading and directing specific equipment requalification and initial qualification activities across the Runcorn site in order to maintain aseptic compliance. 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.

Key Results Areas:

• On-time execution of site validation plans across all functions and systems.
• Zero critical or major validation observations during regulatory inspections.
• Effective planning and resource coordination across departments to meet project and production goals.
• Improved capability and performance across the validation teams.
• Continuous improvement in validation strategy and reduction in cycle times or redundant effort.

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.
• 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 as required.

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.
• Ownership, development and delivery of site equipment re-qualification schedule and integration into the site Validation Master Plan (VMP), ensuring alignment with global Teva standards, cGMP, and regulatory expectations.
• Provide 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.

Integrated Planning & Execution

• Coordinate day-to-day validation activities across shifts and functions to ensure efficient execution against the agreed plan.
• Collaborate closely with Operations, MS&T, Quality, Engineering, supply chain and IT to align validation schedules with manufacturing priorities and project timelines.
• Monitor progress against key milestones, escalate barriers, and adjust plans dynamically in response to changing site needs.
• Serve as a validation leader, chairing stakeholder meetings to ensure transparency of team capacity, risks, and deliverables.

Compliance & Audit Readiness

• Ensure validation activities are compliant with cGMP, GEP, and applicable Teva Standards and global regulatory expectations.
• Maintain audit readiness at all times; lead preparation for and participate in internal and external inspections.
• Own the validation-related CAPAs, Deviations, and Change Controls (DRs, CCMs), ensuring timely closure and zero overdue metrics.
• Lead validation response to audits and inspections, providing data, records, and SME representation as needed.
• Ensure validation documentation is complete, audit-ready, and reflective of current regulatory requirements.

Continuous Improvement & Technical Innovation

• Drive improvements in validation strategy, templates, processes, and documentation.
• Demonstrated ability to challenge current processes and procedures to drive continuous improvements whilst maintaining regulatory compliance.
• Regularly review equipment performance, including Steam-in-Place systems, thermal mapping data and smoke visualisation and implement system upgrades or process enhancements.
• Shadow validation team to identify gaps or improvement opportunities in equipment, documentation, and working practices.

EHS and Site Leadership

• Promote and uphold a proactive EHS culture across all validation activities.
• Ensure procedures, plans, and work practices are aligned with safety expectations.
• Actively participate in tier meetings, site KPI tracking, and EHS event reporting.
• Generate relevant summary information for presenting at SQC and attend as appropriate.

Who We’re Looking For

Do You Have?

• Degree qualification in a scientific or engineering field (or equivalent technical competence/experience).
• Relevant leadership experience, not necessarily of a validation team, but certainly a function that’s linked to validation.
• Experience in Managing Change and Continuous Improvement through people.
• Extensive experience in pharmaceutical validation, ensuring regulatory compliance, team management, and cross-functional coordination.
• Understanding of GxP principles, GAMP 5, data integrity guidance, and international regulatory expectations (MHRA, FDA, EMA).

Are You?

• Able to deliver high performance standards.
• A good communicator/motivator/team player, with high attention to detail required.
• Able to lead and deliver within a matrix environment, balancing strategic objectives with tactical delivery.
• Experienced in setting & managing priorities to consistently deliver on time against tight project timelines.

What We Offer

• 25 paid annual leave days per year
• Private healthcare scheme through Bupa.
• A formal training and development programme specific to your role and department.
• Company pension - flexible employee and employer contributions.
• Competitive salary.
• Employee assistance programme.
• A number of health benefits including: Life Assurance, Critical Illness Insurance, Income protection.
• Plus many other flexible benefits via salary sacrifice: Cycle to work scheme, online and in store discounts and much more.

Application deadline for internal candidates will close on Tuesday 1st July 2025.