Qualification and Validation Lead

UCB; Eigenbrakel; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

UCB, located in Waals-Brabant, Belgium, is seeking a Qualification and Validation Lead to contribute to designing a biologics manufacturing facility. Your role will ensure that manufacturing systems comply with regulatory and quality requirements, supporting a culture of compliance and readiness for inspections.

The ideal candidate will have extensive experience in qualification and validation, strong analytical skills, and a solid understanding of GMP regulations. Fluency in English is essential, and knowledge of French is a plus.

Qualifications

• Experience in qualification and validation within regulated environments.
• Knowledge of GMP requirements and regulatory expectations.
• Experience supporting audits and regulatory inspections.
• Strong ability to analyse and interpret technical documentation.
• Strong communication and collaboration skills.
• Willingness to adapt to project variabilities and a rapidly evolving work environment.
• Fluent in English; French is an advantage.
• Occasional travel to the United States may be required.

Responsabilités

• Define and represent qualification and validation requirements.
• Ensure compliance with regulatory and quality standards.
• Review and assess technical documentation related to validation.
• Contribute to inspection readiness and audit support.
• Translate operational expectations into project requirements.
• Promote a strong quality and compliance culture.

Connaissances

Qualification and validation

Regulatory compliance

GMP knowledge

Technical documentation analysis

Strong communication

Collaboration

Adaptability

Fluency in English

French language

Description du poste

Qualification and Validation Lead

UCB is investing in a new state‑of‑the‑art biologics manufacturing campus in Georgia, USA, to strengthen our global manufacturing network and support future medicines. In this role you will contribute to the design and delivery of a future‑ready facility while ensuring compliance with regulatory and quality requirements.

This role contributes to the design and delivery of a future‑ready biologics manufacturing facility. You will ensure that manufacturing systems, equipment, and processes are designed and delivered in compliance with regulatory and quality requirements. You will contribute to building a compliant and inspection‑ready facility by integrating validation principles throughout the project lifecycle in a rapidly evolving project environment.

Who You’ll Work With

You will work with a team that collaborates with manufacturing sites, quality experts, and project stakeholders. The team focuses on ensuring compliance, alignment with regulatory expectations, and readiness for inspections across different time zones.

What You’ll Do

• Define and represent qualification and validation requirements across the project.
• Ensure compliance with regulatory and quality standards throughout design and delivery.
• Review and assess technical documentation related to validation activities.
• Contribute to inspection readiness and support audit and regulatory interactions.
• Translate operational and regulatory expectations into project requirements.
• Promote a strong quality and compliance culture across stakeholders.

Qualifications

• Experience in qualification and validation within regulated environments.
• Knowledge of GMP requirements and regulatory expectations.
• Experience supporting audits and regulatory inspections.
• Strong ability to analyse and interpret technical documentation.
• Strong communication and collaboration skills.
• Willingness to adapt to project variabilities and a rapidly evolving work environment.
• Fluent in English; French is an advantage.
• Occasional travel to the United States may be required during conceptual design and basic design phases.

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.