Senior CQV Engineer

Are you ready to lead commissioning, qualification, and validation that brings lifesaving biologics closer to patients who need them most? Do you thrive on turning complex bioprocess systems into reliable, compliant, and inspection-ready operations?

As a Senior CQV Engineer, you will be central to delivering new product introductions and continuous improvements across our bulk drug substance facility. You will translate engineering rigor into patient impact by ensuring systems are commissioned safely, qualified efficiently, and sustained with discipline. Working hand-in-hand with operations, quality, automation, and engineering teams, you will accelerate readiness for manufacturing while strengthening our compliance posture and enabling innovation.

Accountabilities:

• Commissioning and Qualification Leadership: Own end-to-end CQV delivery for equipment and utilities in the facility, ensuring systems are released to operations safely, compliantly, and on schedule.
• Risk-Based Verification: Apply risk-based methodologies to streamline commissioning and qualification of new and modified equipment, focusing effort where it creates the greatest assurance and value.
• Upstream/Downstream Automation Integration: Execute commissioning of upstream and downstream biopharma systems integrated with DeltaV, ensuring robust automation handshakes and reliable batch execution.
• Live Equipment Testing and EHS: Plan and lead CQV testing on live equipment, embedding EHS requirements and safe systems of work across sustaining operations, shutdowns, and commissioning activities.
• Regulatory and GxP Compliance: Ensure validation activities meet regulatory and GxP standards; support inspections with clear documentation, traceability, and audit readiness.
• NPI Delivery and Project Partnership: Partner with project and capital teams to integrate CQV requirements into plans, enabling accurate budgets, realistic schedules, and effective startup.
• Issue Resolution and CAPA Ownership: Lead investigations during commissioning and sustaining phases; drive timely closure of safety and compliance-related CAPAs with sound engineering principles.
• Digital Validation and Documentation: Prepare test documentation and champion digital execution using Kneat, improving traceability, cycle time, and data integrity.
• Performance Insights and Continuous Improvement: Collect and analyze data to identify process improvements; implement and test enhancements that increase reliability, reduce risk, and shorten validation timelines.
• Stakeholder Engagement: Build strong relationships across operations, technical services, engineering, automation, and quality to align priorities and deliver manufacturing-critical initiatives as committed.
• Safety Advocacy: Be a visible champion for safe working practices and safety initiatives, reinforcing a culture of care and accountability.

Essential Skills/Experience:

• Complete equipment commissioning and qualification within the BDS facility and supporting utility areas.
• Deliver the CQV scope of New Product Introductions (NPI) to the facility on schedule and within the applicable resource planner.
• Utilize the risk-based verification approach in streamlining ways to commission and qualify new or modified equipment.
• Complete commissioning of upstream/downstream systems in a biopharma environment with DeltaV automation.
• Oversee the planning and execution of CQV testing on live equipment in a safe and compliant manner.
• Understand and implement EHS requirements for CQV teams and how they apply in normal sustaining operations or major shutdown situations and commissioning activities.
• Work with all departments to ensure safety and compliance-related investigations and CAPAs are closed on time and with correct engineering principles applied.
• Liaise with the capital projects team onsite to ensure CQV input into project planning, allowing accurate budget and schedule build.
• Responsible for ensuring all regulatory and GxP compliance items related to validation are satisfied.
• Support regulatory inspections in all elements of BDS equipment qualification.
• Lead investigations to proactively solve problems during commissioning and sustaining phases.
• Preparation of test documentation and support the digital execution of documents (Kneat).
• Conduct data collection and analysis to identify process improvements.
• Implementation and testing of improvement projects within the CQV team.
• Practical problem solving and root cause analysis within cross-functional teams.
• Develop relationships with all key stakeholders within the facility (Operations, Technical Services, Engineering, Automation, Quality) to ensure that critical projects and initiatives related to BDS manufacturing are completed as per timelines.
• Be a champion for safe working practices and safety initiatives.

Desirable Skills/Experience:

• Degree in engineering, pharmaceutical sciences, or related discipline.
• Deep knowledge of biopharma unit operations and DeltaV automation strategies.
• Experience with digital validation platforms (Kneat) and data integrity principles.
• Demonstrated success supporting regulatory inspections and responding to findings.
• Lean Six Sigma or similar continuous improvement certification.
• Strong project management capability; PMP or equivalent is an advantage.
• Formal training in EHS and safe systems of work in GMP environments.
• Advanced root cause analysis and statistical problem-solving skills.
• Track record of delivering NPI start-ups in a GMP manufacturing facility.

Why AstraZeneca:
You will join a community that pairs the agility of a biotech mindset with the scale and scientific depth of a global biopharma. We bring unexpected teams into the same room to unlock bold thinking, and we value kindness alongside ambition. Your CQV leadership will help deliver therapies for people with serious, often underserved conditions—work that is both technically challenging and deeply meaningful. You will have the autonomy to innovate, the support to grow, and the chance to see your engineering decisions turn into real-world patient impact.

Call to Action:
Step into a role where your CQV expertise accelerates breakthrough medicines—bring your best and help us build systems that deliver for patients, every day!

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.