AstraZeneca

Introduction to the Role

The Global Engineering Principal SME Computerised System Validation (CSV) will need to utilise AZ Risk Based Qualification Approach and AZ IT policies to develop project specific requirements and deliverables. This position requires a background with technical and regulatory appreciation.

They will lead initial programme definition and monitor execution for Automation Systems and GMP utilities CSV, which will be integrated into the project qualification exercise. This integrated approach, will support the cross-functional technical teams that are delivering the Automation systems.

Accountabilities/Responsibilities

Reporting to Head of Operational Technology & Connectivity this SME will be responsible for establishing and verifying delivery of computerised system validation requirements and documentation. This will include:

• Establish and deliver plan to develop CSV policy, guidance and procedures. Make suggestions to process owners for improvements and supporting through to resolution.
• Develop and implement CSV program requirements and tools and templates to implement them, always promoting lean working.
• Develop and implement CSV strategy and requirements to achieve delivery of compliant production requirements.
• Provide CSV input and direction to inventory teams and programme management during project execution.
• Have excellent interpersonal skills and the ability to communicate well with a variety of stakeholders including subcontractors, consultants, peers and system vendors.
• Presenting CSV program requirements to senior management for their support and to secure resources.

Responsible for support to SCADA, MES and GMP utility Work Package Owners during project execution to include:

• Authoring of Computerised System validation plans and reports.
• Manage, monitor and document vendors’ status with respect to the delivery of compliant computerized systems.
• Establish and deliver clear CSV activities and deliverables for each major capital project. These will be aligned with project sanctioned cost and scheduled goals. The Project Support Plan (PSP) will be followed and executed in accordance with the key project milestones.
• Monitoring of validation elements to ensure they follow program requirements appropriate for the specific system/inventory to deliver design intent and meet quality standards. This will include coaching and mentoring of delivery team members in CSV, GAMP5, etc.
• Develop strategies to mitigate issues and risks identified during project execution (e.g. during code reviews, functional testing, supplier deficiencies vs agreements, etc.).
• Identify requirement for supporting artefacts (i.e. soft controls, such as Computer System SOPs for user access control, Business Continuity Plans, Batch Report retrieval, etc.) to meet IS policy and Qualification Plan CSV requirements.

Minimum Requirements – Education and Experience

• Fluent Chinese and English.
• Bachelor’s degree in engineering or related technical field.
• At least 6 years of pharmaceutical experience.
• Deep knowledge of current GMP regulations and an understanding of regulatory agency expectations and current industry practices as they relate to commissioning and qualification best practices.
• Excellent communications skills with a positive, solutions-focussed manner.

Desirable Qualifications and Experience

• MBA, or related business experience.
• Managerial / Supervisory experience.
• Experience of working in a Lean environment.
• Experience in the procurement and execution of CSV services supporting capital projects.

Date Posted

17-6月-2025

Closing Date

29-9月-2025

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.