Quality Engineer CSV
First seen by Alion on Aug 6, 2026. SIRE Life Sciences scores B on the Alion truth index.
Our client is a globally recognized leader in the cell therapy and biopharmaceutical industry, dedicated to developing innovative treatments for patients with serious diseases. Operating in a highly regulated GMP environment, the organization combines cutting-edge technology with a strong quality culture, offering professionals the opportunity to work on advanced manufacturing systems that directly contribute to life-changing therapies. The company values collaboration, continuous improvement, and operational excellence.
About the Role
We are looking for an experienced Senior Quality Engineer I - Computer System Validation (CSV) to join a quality team supporting Manufacturing Execution System (MES) projects. In this role, you will provide quality oversight for computer system validation activities, ensuring that manufacturing systems remain compliant with GMP and regulatory requirements. You will collaborate closely with engineering, validation, and manufacturing teams while helping drive quality improvements across the site.
Responsibilities
- Provide quality oversight for Computer System Validation (CSV) activities related to MES projects.
- Review and approve validation documentation, including new system qualifications, system changes, and periodic revalidation.
- Ensure computerized systems comply with GMP and regulatory expectations.
- Support Continuous Commissioning, Qualification & Validation (CQV) activities from a quality perspective.
- Participate in Quality Risk Management activities and assess the impact of system changes.
- Help develop and monitor quality KPIs to identify improvement opportunities.
- Investigate quality deviations and contribute to effective corrective and preventive actions.
- Work closely with cross-functional teams to maintain high standards of quality and compliance.
- Contribute to process improvements and support inspection and audit readiness.
Qualifications
- Bachelor's degree (BSc) in Engineering, Life Sciences, Computer Science, or a related technical field.
Required Skills
- Proven experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical, biotechnology, or medical device environment.
- Hands-on experience with Werum PAS-X is mandatory.
- Strong understanding of GMP, computerized system validation, and regulatory compliance.
- Experience reviewing and approving validation documentation.
- Excellent communication and technical writing skills.
- Ability to work independently while collaborating effectively with multidisciplinary teams.
Preferred Skills
- Experience with Quality Risk Management tools such as FMEA or HACCP is an advantage.
- Knowledge of Lean Six Sigma or DMAIC methodologies is considered a plus.
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