Lead Engineer - Lab Metrology & Qualification

Baxter Healthcare; Eigenbrakel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Baxter Healthcare in Belgium seeks a Principal Engineer, Operations Metrology & Qualification, to provide technical leadership for qualification and validation of laboratory equipment and systems. You will drive compliance, continuous improvement, and lifecycle management across a highly regulated GMP environment.

You will mentor engineers and technicians, coordinate with vendors, and lead cross-functional projects to ensure reliability, data integrity, and audit readiness across the site in

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, or related field.
• Minimum 5 years in equipment qualification, metrology, CSV, or analytical lab engineering in regulated industries.
• Strong expertise in analytical instrumentation, data integrity, CSV, equipment lifecycle management, and GMP.
• Demonstrated experience leading complex technical projects and influencing cross-functional stakeholders.
• Ability to manage multiple priorities in a dynamic environment while maintaining quality and compliance.
• Fluent in English and French (written and spoken).

Responsabilités

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

Connaissances

Analytical skills

Problem solving

Communication

Stakeholder management

Project leadership

Formation

Master's degree

Description du poste

Baxter Healthcare in Belgium seeks a Principal Engineer, Operations Metrology & Qualification, to provide technical leadership for qualification and validation of laboratory equipment and systems. You will drive compliance, continuous improvement, and lifecycle management across a highly regulated GMP environment.

You will mentor engineers and technicians, coordinate with vendors, and lead cross-functional projects to ensure reliability, data integrity, and audit readiness across the site in