Commissioning, Qualification & Validation (CQV) Project Lead

Job Description Are you ready to lead risk-based CQV that brings new medicines online faster and safer? Do you thrive on connecting science-led validation with real-world production timelines to protect patient trust? In this role, you will orchestrate commissioning, qualification and validation across equipment, utilities and digital systems, turning complex change into release readiness. You will partner closely with engineering, manufacturing, automation/IT, quality and vendors to achieve first-time-right outcomes, reduce deviation aging and meet go/no-go criteria without compromising compliance. You will work across diversified tasks with a global team, benefiting from cross-functional perspectives and new ways of thinking. Your leadership will align technical rigor with delivery speed, helping scale new technologies and get our pipeline to patients reliably. This full-time maximum term (24 months) contract position is located in Macquarie Park, Sydney and the base salary range is AUD 100,000 – 120,000 per annum. About AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology; Cardiovascular, Renal and Metabolism (CVRM); Respiratory & Immunology (R&I); and Rare Disease. At AstraZeneca Australia, we have been working to deliver the best value to patients for more than 60 years, and we push the boundaries of science to deliver life-changing medicines. Help to foster an environment of trust in our complex and everchanging manufacturing sites. It means making our sites more than a place to work, but a home for our ‘family’ where you feel supported and can have fun whilst working on interesting challenges. Key Responsibilities: CQV Strategy and Planning: Define and execute a risk-based CQV plan covering scope, critical aspects, acceptance criteria, test phases (FAT/SAT, commissioning, IQ/OQ/PQ/PPQ), resourcing, and deviation/CAPA, adjusting as projects evolve to enable timely release readiness. Scope and Protocols: Consolidate scope with Quality, Engineering, Operations, and Automation/IT; lead URS, risk assessments, RTM, and DQ/IQ/OQ/PQ/PPQ protocol/report development; drive approvals to ensure traceable, science-based coverage. Execution Management: Coordinate FAT/SAT, commissioning, and qualification with internal teams and vendors; track progress, verify exit criteria, and drive timely deviation/CAPA closure and retest to protect schedule and compliance. Tooling and Readiness: Enable teams on digital validation/test tools and change control; set up utilities, materials, and data; maintain configuration and document control per ALCOA+ to safeguard data integrity and reproducibility. Governance and Training: Ensure GxP and AstraZeneca standards compliance; confirm training completion, produce CQV summary reports, and manage sign offs and handover to support audit readiness and operational entry. System Validation and Release: Complete and document validation, including CSV for PLC/SCADA/DCS/MES/BMS/EMS; secure approvals for production entry to unlock dependable manufacturing. Policy and Standards: Develop and review project CQV strategies; contribute to validation policies, standards, templates, and continuous improvement to elevate consistency and efficiency. Stakeholder Engagement: Align CQV plans with PM, System Owner, Quality, Engineering, EHS, Automation/IT, and vendors; communicate CQV needs across tech transfer, process validation, integration testing, release, and operational readiness to avoid late-stage surprises. Resource Coordination: Secure SME, technician/tester, and vendor availability; proactively flag delays or constraints affecting CQV execution to protect critical path. Schedule and Cost Control: Execute action plans to meet timelines and budgets; manage equipment resources and costs to keep delivery on track. Metrics and Reporting: Track progress, coverage, first-time-right, deviations, readiness, and exit criteria; document status, risks, dependencies, and go/no-go recommendations for transparent decision-making. Coaching: Provide day-to-day leadership and coordination of CQV execution teams and vendor testers; coach SMEs on lean, science- and risk-based validation practices and data integrity expectations. Communication and Audit Readiness: Ensure clear communication across relevant departments; facilitate reviews and approvals; support inspection readiness and knowledge sharing to strengthen compliance culture. Essential for the role Bachelor’s degree in Engineering or Science (e.g., Chemical, Mechanical, Electrical, Biomedical, Pharmaceutical). Proven CQV/Validation/Engineering experience within GMP-regulated pharma/biotech, leading commissioning and qualification for facilities, clean utilities, HVAC, process equipment and automated systems. Practical experience across lifecycle and traceability (URS/RTM, DQ/IQ/OQ/PQ/PPQ), deviation/CAPA and change control; strong grasp of system lifecycle management, release management and maintenance handover. Working knowledge of EU GMP Annex 15, ICH Q9/Q10, 21 CFR 210/211, 21 CFR Part 11, ISPE Baseline Guides and GAMP 5. Ability to interpret P&IDs, URS, FRS, design specifications and automation cause-and-effect; proficiency with test/document management tools. Strong communication, stakeholder management, analytical problem solving, risk management and escalation; adaptable in fast-paced environments; experience defining/reporting CQV metrics and onboarding execution teams to protocols and data integrity expectations. Desirable for the role Master’s degree or relevant certifications (e.g., PMP, CQV/Validation, CMQ/OE). Experience in sterile/aseptic operations, biologics or highly regulated manufacturing; audit/inspection readiness. Exposure to automated test tools/frameworks for OT/IT; understanding of MES, historians, data analytics and OT cybersecurity expectations. Familiarity with AstraZeneca quality systems and global engineering standards. Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. So, what’s next! Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours. Where can I find out more? Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/ Visit our website: www.astrazeneca.com.au AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Gold Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - www.astrazeneca.com.au/careers.html to learn more about our commitment to fostering a flexible, diverse, and inclusive environment. We recognise that any recruitment process may present challenges, if there is anything we can do to make our recruitment process more accessible for you, please let us know via this Form . Date Posted 19-Jan-2026 Closing Date 27-Feb-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.