Lead Engineer, Lab Metrology & Qualification

Zvh; Belgique; Sur place; EUR 85 000 - 120 000; Plein temps

Résumé du poste

Baxter in Belgium (Braine-l'Alleud) is seeking a Principal Engineer, Operations Metrology & Qualification to provide technical leadership for laboratory equipment qualification, metrology programs, CSV, and lifecycle management across the site.

You will drive compliance with GMP, GDP, data integrity, and FDA 21 CFR Part 11, collaborating with Quality, Engineering, Manufacturing and Laboratory teams to deliver reliable equipment performance and continuous improvement.

Qualifications

• Master's degree required in a relevant scientific discipline.
• Minimum 5 years in equipment qualification, metrology or CSV in regulated industries.
• Strong expertise in analytical instrumentation and data integrity.
• Experience leading cross-functional projects and influencing stakeholders.
• Fluent in English and French (written and spoken).

Responsabilités

• Provide technical leadership for qualification, validation, calibration, and lifecycle management of laboratory equipment and systems.
• Lead complex qualification and validation projects from conception through implementation while ensuring compliance, quality, budget, and timeline objectives.
• Develop, review, approve, and execute qualification and validation documentation (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, reports, reviews).
• Act as Subject Matter Expert for analytical instrumentation, laboratory computerized systems, metrology practices, data integrity, regulatory requirements.
• Support selection, acquisition, commissioning, implementation, and lifecycle management of new lab technologies.
• Lead technical investigations related to equipment failures, deviations, non-conformances, identifying root causes and CAPA.
• Ensure compliance with GMP, GDP, Data Integrity, FDA 21 CFR Part 11, Annex 11, Baxter quality standards.
• Coordinate and oversee activities by external vendors and service providers.
• Mentor and support engineers, technicians, and laboratory personnel.
• Support audit and inspection readiness and represent function during regulatory and customer audits.
• Drive continuous improvement initiatives to enhance equipment reliability and qualification efficiency.

Connaissances

Equipment qualification

Metrology

CSV (Computerized Systems Validation)

Analytical instrumentation

Project leadership

Cross-functional collaboration

Problem solving

English and French fluency

Formation

Master's degree in Engineering or related field

Description du poste

Baxter in Belgium (Braine-l'Alleud) is seeking a Principal Engineer, Operations Metrology & Qualification to provide technical leadership for laboratory equipment qualification, metrology programs, CSV, and lifecycle management across the site.

You will drive compliance with GMP, GDP, data integrity, and FDA 21 CFR Part 11, collaborating with Quality, Engineering, Manufacturing and Laboratory teams to deliver reliable equipment performance and continuous improvement.