Senior Quality Engineer Csv

Looking to have your CSV and Quality Oversight skills contribute to improve the lives of cancer patients all over the world?, This new Senior Quality Engineer CSV position allows you to do exactly that, as you’ll be responsible for supporting Manufacturing Execution System (MES) projects through Quality Oversight and Quality Risk Management oversight activities., * Support KPI development to drive improvement initiatives across the organization.

• Help implement process changes and review/approve CSV validation and revalidation deliverables.
• Ensure compliance with regulatory requirements, GMP, and quality processes.
• Maintain quality programs and support complex issue resolution, deviation assessment, and impact evaluation.
• Work with cross-functional teams and operating entities to support inspections, SPC analyses, audits, and site quality oversight activities.
• Manage priorities independently on routine work and support CQV and Quality Risk Management oversight for the site.

• BSc diploma in relevant area such as Engineering, Computer Science, Information Technology / Information Systems;
• Relevant experience in the application of Quality principles, concepts, industry practices, and standards;
• Knowledge and experience with Werum PAS-X;
• Clear communication, technical writing and good interpersonal skills; Preferably: Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, or Risk Management tools (eg: HACCP); *

Our client is a biopharmaceutical company located in Hoofddorp, focused on the development and commercialization of novel cancer immunotherapy products, designed to restore the patient’s immune system to recognize and eradicate tumors, that are shipped to and from all across Europe. Their state-of-the-art facility includes MP/ML-II cleanrooms, GMP warehouses, quality control lab, PCR lab, offices, learning environments, auditing rooms, a town hall, auditorium and a restaurant., Gi Life Sciences supports leading pharmaceutical, biotech and medical device companies with specialized recruitment and workforce solutions, by combining deep sector knowledge with a strong network of life sciences professionals.

Our approach is hands-on and partnership-driven: we listen to your needs, move quickly, and focus on long-term fit, compliance and candidate experience, to match the right talent to the right projects across manufacturing, quality, engineering, R&D, regulatory and supply chain.