Senior Quality Project Engineer

Cytiva; Hoegaarden; Sur place; EUR 75 000 - 95 000; Plein temps

Résumé du poste

Cytiva in Hoegaarden, Belgium is seeking a Senior Quality Project Engineer to lead quality across NPD, product sustainment, customization and transfer of work.

You will be a core member of cross-functional teams, ensuring quality, regulatory and compliance requirements are integrated throughout the product lifecycle and reporting to the Director QA – Single Use Technologies, Projects and Continuous Improvement.

Qualifications

• Master or bachelor’s degree in applicable field or equivalent by experience in Quality in GMP/ISO regulated environments.
• Experience in validation/qualification and project management is required.
• Knowledge of ISO9001 and/or ISO13485 regulatory standards.

Responsabilités

• Provide quality oversight during design transfer, process development, verification, validation, and commercialization.
• Support transfer of products and processes from development to routine manufacturing with robust quality controls.
• Collaborate with Product Management, RD&E, Manufacturing Engineering, Regulatory Affairs, Supply Chain, and QA functions to ensure successful project execution.
• Author, review, approve, and maintain validation protocols and reports in compliance with procedures.
• Utilize investigations, CAPAs, non-conformances, and audit observations to drive continuous improvement and quality-by-design in development.

Connaissances

Quality leadership

Cross-functional teamwork

Project management

Validation/Qualification

GMP/ISO knowledge

Travel readiness

Formation

Master's degree in relevant field

Bachelor's degree in relevant field

Description du poste

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible.

Senior Quality Project Engineer is responsible for providing quality leadership for business-initiated projects, including New Product Development (NPD), product sustainment, customization, innovation initiatives, and Transfer of Work (ToW) activities. As a core member of cross-functional project teams, the Senior Quality Project Engineer represents the Quality function and ensures that quality, regulatory, and compliance requirements are effectively integrated throughout the entire product and process lifecycle. This position reports to the Director QA – Single Use Technologies, Projects and Continuous improvement and is part of the Upstream and Fluid Management QA & RA organization located in Hoegaarden, Belgium and will be an on-site role.

What You Will Do

• Provide quality oversight and guidance throughout design transfer, process development, verification, validation, and commercialization activities.
• Support successful transfer of products and processes from development to routine manufacturing, establishing robust quality controls and monitoring strategies to ensure consistent product quality and process performance.
• Partner with Product Management, RD&E, Manufacturing Engineering, Regulatory Affairs, Supply Chain, Supplier Quality, Global Sterility Assurance and Operations to support robust product and process development while ensuring successful project execution
• Author, review, approve, and maintain validation protocols, reports, and other quality-related project documentation in compliance with applicable procedures and standards.
• Leverage complaint investigations, CAPAs, non-conformances, audit observations, and other quality data sources to drive continuous improvement and strengthen quality-by-design principles within product development activities

Who You Are

• Master or bachelor’s degree in applicable field or equivalent by experience in Quality in a similar (GMP)/ISO regulated BU/Industry.
• 5 + years of relevant quality experience of which at least 3 years of applicable industry experience.
• Can work independently as a quality lead within a cross-functional team to support successful implementation of new projects and products.
• Validation/qualification experience and project management are a must.
• Strong working knowledge of quality assurance principles and practices, industry and international regulations and standards (ISO9001 and/or ISO134585).

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel 5-15% (domestic and international).

It would be a plus if you also possess previous experience in:

• Knowledge of ISO11137, ISO14644 and ISO14698 is a plus.
• Statistical improvement tools and lean manufacturing techniques.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.