Engineering Validation Manager

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 and we currently have a fantastic opportunity for a Engineering Validation Manager to join our team on a Full Time, Permanent basis in Runcorn.

At Teva Runcorn, we develop, manufacture and market innovative and affordable medicines, specialising in sterile liquid products mainly used for treating respiratory conditions using Blow-Fill-Seal technology as well as injectable Combination Products such as our MS treatment Copaxone.

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.

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.

Computer System Validation (CSV) & Data Integrity
•    Provide governance for all site-level computerised systems requiring re-validation in accordance with GAMP 5 and 21 CFR Part 11 / Annex 11 requirements.
•    Provide support for periodic reviews, audit trail reviews, and system remediation efforts.
•    Promote a culture of data integrity, ensuring systems are appropriately assessed, validated, and maintained throughout their lifecycle.

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.
•    Regularly review equipment and process performance, including Sterilise-in-Place systems and thermal mapping data, and implement system upgrades or process enhancements.
•    Shadow validation technicians 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.

Enjoy a more rewarding choice

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 validation, including regulatory compliance and cross-functional coordination in a highly regulated industry.
• An 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. 

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

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

Teva’s Equal Employment Opportunity Commitment