Senior Principal Engineer, Lab Metrology & Validation

Baxter International Inc.; Eigenbrakel; Sur place; EUR 90 000 - 125 000; Plein temps

Résumé du poste

Baxter International Inc. in Belgium is seeking a Principal Engineer, Operations Metrology & Qualification to provide technical leadership for laboratory equipment qualification, metrology programs, and CSV lifecycle management across the site.

You will drive compliance with GMP, GDP, and 21 CFR Part 11, mentor engineers, manage external vendors, and lead complex qualification projects from concept to implementation, while enabling continuous improvement in a highly regulated environment.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, or related field.
• Minimum 5 years experience in equipment qualification, metrology, CSV, or analytical lab engineering.
• Strong expertise in analytical instrumentation, data integrity, CSV, lifecycle management, GMP.
• Experience leading complex technical projects and influencing cross-functional stakeholders.
• Ability to manage multiple priorities in a dynamic, compliant environment.
• 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/validation projects from conception through implementation with quality, budget, and timeline objectives.
• Develop, review, approve, and execute qualification and validation documentation (IQ/OQ/PQ, URS, Risk Assessments).
• Act as Subject Matter Expert for analytical instrumentation, lab systems, metrology, data integrity, and regulatory requirements.
• Support selection, acquisition, commissioning, and lifecycle management of new laboratory technologies.
• Lead investigations of equipment failures, deviations, and non-conformances with effective CAPA.
• Ensure GMP, GDP, Data Integrity, and FDA 21 CFR Part 11/Annex 11 compliance; coordinate audits.
• Mentor engineers and technicians; provide technical coaching and knowledge sharing.
• Support audit readiness and represent the function in regulatory and customer audits.
• Drive continuous improvement to enhance equipment reliability, qualification efficiency, and lab performance.

Connaissances

Project leadership

Cross-functional collaboration

Analytical instrumentation

Data integrity

Regulatory compliance

English & French

Formation

Master's degree in Engineering

Description du poste

Baxter International Inc. in Belgium is seeking a Principal Engineer, Operations Metrology & Qualification to provide technical leadership for laboratory equipment qualification, metrology programs, and CSV lifecycle management across the site.

You will drive compliance with GMP, GDP, and 21 CFR Part 11, mentor engineers, manage external vendors, and lead complex qualification projects from concept to implementation, while enabling continuous improvement in a highly regulated environment.