CSV Lead

Are you ready to lead computer system validation that safeguards data integrity and accelerates reliable manufacturing for people living with rare diseases? As CSV Lead Engineer, you will shape the digital backbone of GMP operations, driving compliant performance across MES, DeltaV and other critical systems that keep vital therapies moving.

In this role, you will turn regulations into practical testing strategies and risk-based validation, guiding teams across Bulk Drug Substance, Packaging and Laboratory areas. Your decisions will simplify qualification, strengthen data integrity, and reduce time to implement new equipment and systems. Do you see opportunities to streamline while raising the bar on compliance and quality?

Accountabilities:
- Validation Leadership: Serve as the subject matter expert for GMP computer systems, including MES and DeltaV, setting direction, standards and best practices.
- Regulatory Alignment: Ensure validation strategies align with GAMP 5, cGMP, 21 CFR Part 11 and internal procedures to enable timely introduction of new computerized systems and equipment.
- Testing Strategy and Execution: Develop fit-for-purpose testing plans that uphold data integrity; oversee and perform CSV activities from commissioning through qualification.
- Design and Documentation Review: Review specifications, design, installation and validation documentation to confirm fitness for use, traceability and compliance.
- Risk Assessment: Lead and participate in Validation Risk Assessments to determine appropriate testing depth for new equipment and changes.
- Lifecycle Management: Provide validation support and process improvements to existing systems and equipment; complete periodic reviews and close identified gaps.
- Deviation and Investigation Management: Generate and resolve protocol discrepancies and deviations; lead investigations and remediate potential data integrity issues.
- Inspection Readiness: Prepare and support regulatory and internal inspections, demonstrating control and transparency of computerized systems.
- Safety and Commissioning: Champion safe working practices; plan and execute commissioning activities in adherence to site safety procedures.
- SOP and Governance Contribution: Input into Operations, Qualification and Validation SOPs to strengthen governance and consistency across the site.

Essential Skills/Experience:
- Subject matter expertise in validation for GMP manufacturing computer systems, including MES and DeltaV.
- Proven experience overseeing and performing computer system validation activities.
- Deep understanding of applicable regulations, GAMP 5, cGMP and 21 CFR Part 11, and ability to align validation approaches with internal procedures.
- Ability to develop standard testing plans that ensure the integrity of data produced by process equipment and computerized systems.
- Proficiency in reviewing equipment specifications, design, installation and validation documentation.
- Experience providing validation support and process improvements to existing computerized systems and equipment.
- Guidance capability on activities related to computer and automation systems validation.
- Participation in Validation Risk Assessments to determine testing requirements for new equipment.
- Evaluation of systems and equipment against cGMP, Part 11 and other regulatory requirements.
- Support for sustaining and project CSV activities across Bulk Drug Substance, Packaging and Laboratory areas.
- Contribution to Operations, Qualification and Validation SOPs.
- Experience drafting, reviewing and approving validation documentation.
- Skill in generating and resolving protocol discrepancies and deviations.
- Leadership in investigations to resolve potential data integrity issues during validation studies and operations.
- Ability to complete periodic reviews for computerized systems and investigate any identified gaps.
- Support for regulatory and internal inspections for computerized systems.
- Commitment to safe working practices and safety initiatives within the group.
- Experience leading planning and execution of commissioning activities in adherence to site safety procedures.

Desirable Skills/Experience:
- Degree in Engineering, Computer Science, Life Sciences or a related field.
- Experience in biopharmaceutical manufacturing environments with GMP-regulated computerized systems.
- Hands-on familiarity with MES recipe management and DeltaV configuration and change control.
- Strong understanding of data integrity frameworks, audit trail review and risk-based validation approaches.
- Experience with CAPA, change control processes and periodic review programs.
- Involvement in inspection readiness activities and mock audits.
- Continuous improvement mindset, with exposure to Lean or Six Sigma methodologies.
- Professional training or certification related to GAMP or CSV.
- Strong stakeholder engagement and cross-functional collaboration skills.

Why AstraZeneca:
Here you will join originators who act with urgency and ingenuity to reach people living with rare diseases. You will work where unexpected teams gather in the same room to unleash bold thinking, connect deeply to patient experiences and turn ideas into practical systems that run at scale. We blend the autonomy and energy of a leading biotech with the reach and resources to move fast and do the right thing. We value kindness alongside ambition, and we back technical excellence with real ownership, so your validation leadership directly strengthens the supply of therapies that change lives.

Call to Action:
If you’re ready to lead validation that protects data integrity and powers reliable manufacturing for essential therapies, step forward and shape what comes next!

Date Posted

12-Feb-2026

Closing Date

26-Feb-2026

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.