Principal Engineer, Ops Metrology & Qualification

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

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

At Baxter, we are united by our mission to Save and Sustain Lives. Our Braine-l'Alleud site is a strategic R&D and pharmaceutical operations hub, bringing together scientific expertise, innovation, and technical excellence to support the development and delivery of therapies that improve patients' lives worldwide. Based at our campus in Braine-l'Alleud, you will join a highly collaborative environment where Quality, Engineering, Manufacturing, and Laboratory teams work together to ensure the highest standards of compliance, reliability, and operational excellence.

As Principal Engineer, Operations Metrology & Qualification, you will provide technical leadership for laboratory equipment qualification, metrology programs, computerized systems validation, and lifecycle management activities across the site. Acting as a recognized technical expert, you will drive compliance, performance, and continuous improvement while supporting critical laboratory operations in a highly regulated GMP environment.

What you'll do

• Provide technical leadership for the qualification, validation, calibration, and lifecycle management of laboratory equipment, computerized systems, and supporting utilities.
• Lead complex qualification and validation projects from conception through implementation while ensuring compliance, quality, budget, and timeline objectives are achieved.
• Develop, review, approve, and execute qualification and validation documentation, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, reports, and periodic reviews.
• Act as Subject Matter Expert for analytical instrumentation, laboratory computerized systems, metrology practices, data integrity, and regulatory requirements.
• Support the selection, acquisition, commissioning, implementation, and lifecycle management of new laboratory technologies and systems.
• Lead technical investigations related to equipment failures, deviations, and non-conformances, identifying root causes and implementing effective corrective and preventive actions.
• Ensure compliance with GMP, GDP, Data Integrity requirements, 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 and knowledge sharing.
• Support audit and inspection readiness activities and represent the function during regulatory and customer audits.
• Drive continuous improvement initiatives to enhance equipment reliability, qualification efficiency, compliance, and laboratory performance.

Qualifications & Experience

• Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related scientific discipline.
• Minimum 5 years of experience in equipment qualification, metrology, computerized systems validation, analytical laboratory engineering, or a related field within the pharmaceutical, biotechnology, or other highly regulated industries.
• Strong expertise in analytical instrumentation, data integrity, computerized systems validation (CSV), equipment lifecycle management, and GMP compliance.
• Demonstrated experience leading complex technical projects and influencing cross-functional stakeholders.
• Ability to manage multiple priorities in a dynamic environment while maintaining a high level of quality and compliance.
• Strong analytical, problem-solving, and communication skills, with the ability to translate complex technical topics into clear business decisions.
• Fluent in English and French (written and spoken).

Why Baxter?

This is where your expertise can make a real impact. At Baxter, you'll have the opportunity to influence critical decisions, lead complex technical initiatives, and collaborate with experts across functions and regions. If you're passionate about driving technical excellence, ensuring compliance in a highly regulated environment, and mentoring others while advancing healthcare for millions of patients, we'd love to hear from you.

Join Baxter and help us Save and Sustain Lives.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process,