Principal Engineer, Ops 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

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, let us know the nature of your request along with your contact information.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.