Senior Quality Project Engineer - Life Sciences Impact Leader

Radiometer; Hoegaarden; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

Cytiva in Hoegaarden, Belgium, is seeking a Senior Quality Project Engineer to provide leadership for NPD, product sustainment and ToW projects. You will ensure QA, regulatory and compliance are integrated across the lifecycle, reporting to the Director QA - Single Use Technologies, Projects and Continuous Improvement.

The role requires 5+ years of quality experience, including validation and project management, and the ability to travel 5-15% internationally.

Qualifications

• Master or bachelor’s degree in applicable field or equivalent by experience in Quality in GMP/ISO regulated BU/Industry.
• 5+ years of relevant quality experience, with at least 3 years in industry.
• Independent quality lead within cross-functional teams to implement new projects and products.
• Validation/qualification experience and project management are a must.
• Strong knowledge of QA principles, regulatory standards (ISO9001 and ISO134585).

Responsabilités

• Provide quality oversight across design transfer, process development, verification, validation, and commercialization activities.
• Support transfer of products/processes from development to routine manufacturing with robust quality controls.
• Collaborate with Product Management, R&D, Manufacturing Engineering, Regulatory Affairs, Supply Chain, Supplier Quality, STA and Operations to support robust development and project execution.
• Prepare, review, approve, and maintain validation protocols, reports, and QA documentation in compliance with procedures.
• Utilize complaint investigations, CAPAs, non-conformances, audit observations and data to drive continuous improvement and quality-by-design in development.

Description du poste

Cytiva in Hoegaarden, Belgium, is seeking a Senior Quality Project Engineer to provide leadership for NPD, product sustainment and ToW projects. You will ensure QA, regulatory and compliance are integrated across the lifecycle, reporting to the Director QA - Single Use Technologies, Projects and Continuous Improvement.

The role requires 5+ years of quality experience, including validation and project management, and the ability to travel 5-15% internationally.