As a trusted validation engineer, you will influence projects from concept through operational release, partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT, and help build a culture in which quality, innovation, and compliance strengthen one another. Typical Accountabilities • Lead/coordinate validation strategies and lifecycle deliverables that translate risk, regulatory expectations, and business needs into clear plans, robust testing, traceability, and defensible conclusions. • Guide the qualification and continued control of GMP facilities, utilities, equipment, temperature-controlled storage units, manufacturing systems, and laboratory equipment that support dependable operations. • Direct protocol planning and execution, evaluate installations and changes, and integrate commissioning, calibration, maintenance, and engineering evidence into sound qualification decisions. • Support CSV across the full system lifecycle, developing rigorous requirements, specifications, risk assessments, testing, traceability, and summary documentation for GxP systems. • Provide forward-looking validation impact assessments for software upgrades, patches, infrastructure changes, periodic reviews, and lifecycle maintenance, ensuring systems remain fit for intended use. • Champion cGMP, data integrity, 21 CFR Part 11, EU GMP Annex 1, GAMP 5, site procedures, and company validation standards through practical, risk-based application. • Lead and support deviations, CAPAs, change controls, and investigations, using disciplined root-cause analysis and effectiveness verification to convert issues into lasting improvement. • Represent validation with confidence during internal audits, regulatory inspections, and customer audits, supported by accurate, complete, and inspection-ready documentation. • Elevate the validation program by developing procedures, templates, standards, and risk-based practices that improve consistency, efficiency, and lifecycle governance. • Bring cross-functional teams together around clear priorities, realistic schedules, transparent status, and proactive risk mitigation across Engineering, Manufacturing, Quality, Facilities, MS&T, and IT. • Grow organizational capability by coaching project teams and less-experienced validation colleagues, sharing knowledge, and modeling strong technical judgment and quality leadership. Qualifications and Skills Essential: Bachelor’s degree in Engineering (preferred), Computer Science, Biotechnology, or a related technical discipline; minimum seven years of validation experience in a regulated pharmaceutical, biotechnology, medical-device, or comparable GMP environment; demonstrated experience with CQV for GMP equipment, utilities, facilities, or manufacturing systems; experience supporting CSV throughout the system lifecycle; and a strong record of authoring, reviewing, and approving validation documentation. Strong working knowledge of GMP and GDP requirements, ISPE GAMP 5, risk-based validation, data integrity, 21 CFR Part 11, EU GMP Annex 1, change control and CAPA systems, the DQ/IQ/OQ/PQ lifecycle, Validation Master Plans, and validation maintenance programs. Desirable: Experience supporting cell therapy (clinical/commercial stages), biologics, or sterile manufacturing; MES, ERP, LIMS, SCADA, BMS, EMS, laboratory computerized systems, or similar GxP platforms; Veeva Vault, SAP, paperless validation systems, Blue Mountain, or equivalent systems; temperature mapping, cleanroom and utilities qualification, environmental monitoring systems, and cross-functional project leadership. Date Posted 16-Oct-2026 Closing Date 30-Oct-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

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