Sr. QA Validation Specialist

Lonza; Geleen; Presencial; Confidential; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Agile career culture

Inclusive workplace

Performance-based compensation

Role/location-based benefits

Continuous improvement initiatives

Interface with QA/Engineering/Manufact

Resumo da oferta

Lonza Geleen seeks a Sr. QA Validation Specialist to lead validation for equipment, facilities and utilities, ensuring compliance with cGMP and regulatory standards.

You will oversee documentation, qualification activities and support cross-functional teams in Engineering and Manufacturing to maintain high quality production. This site-based role offers opportunities to influence validation processes, participate in continuous improvement and contribute to global quality standardization within a

Qualificações

• 5–10 years of experience in validation, quality assurance, or related area within a regulated manufacturing environment.
• Bachelor’s or Master’s degree in Engineering, Biology, Biomedical Science, Life Science or related discipline.
• Experience with cGMP, GxP, GAMP and related quality systems, with knowledge of European and FDA expectations.

Responsabilidades

• Oversee qualification and validation activities for equipment, facilities and utilities, ensuring deliverables meet quality and regulatory requirements.
• Review and approve validation documentation (URs, validation plans, design/qualification docs, commissioning, factory/site acceptances).
• Ensure traceability of requirements from URs to performance qualification.
• Assess validation impact and support periodic reviews of validated assets and changes.
• Manage validation deviations and changes with proper documentation and actions.
• Provide quality and compliance support to Engineering, Manufacturing and Technical Services teams.
• Contribute to continuous improvement and standardization of validation processes across the organization.

Conhecimentos

Analytical skills

Problem-solving

Communication skills

Time-management

Cross-functional collaboration

Formação académica

Bachelor’s/Master’s in Engineering or Life Sciences

Descrição da oferta de emprego

Sr.QA Validation Specialist

Geleen, Netherlands

The actual location of this job is in Geleen, Netherlands. Relocation assistance is available for eligible candidates and their families, if needed.

Join Lonza as a Sr. QA Validation Specialist and play a key role in ensuring our facilities, utilities and equipment meet the highest quality and compliance standards. Working within Quality Assurance, you will provide expert oversight of validation activities and collaborate closely with Engineering, Manufacturing and other teams to support the safe, reliable and compliant production of medicines.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.
• Opportunities to contribute to continuous improvement and international standardization.
• The opportunity to work at the interface of Quality Assurance, Engineering and Manufacturing within a global life sciences organization.

The full list of our global benefits can be found here: Lonza global benefits.

The full-time annual base pay for this position in the Netherlands is expected to range between EUR 54,000 and EUR 75,600. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution.

What you will do:

• Oversee qualification and validation activities for equipment, facilities and utilities, ensuring deliverables meet applicable quality and regulatory requirements.
• Review and approve validation documentation, including user requirements, validation plans, design and qualification documents, commissioning documentation, and factory and site acceptance testing.
• Ensure traceability of requirements throughout the validation lifecycle, from user requirements through to performance qualification.
• Assess validation impact and support periodic reviews of validated equipment, facilities and utilities, including changes and improvements.
• Manage validation deviations and changes, ensuring appropriate documentation, corrective actions and follow-up are completed effectively.
• Provide quality and compliance support to Engineering, Manufacturing and Technical Services teams, applying current Good Manufacturing Practice (cGMP) and validation principles.
• Contribute to continuous improvement and standardization of validation processes and practices across the organization.

What we are looking for:

• 5–10 years of relevant experience in validation, quality assurance, quality control, control systems or a related area within a regulated manufacturing environment.
• A technical diploma, bachelor’s or master’s degree in Engineering, Biology, Biomedical Science, Life Science or a related discipline.
• Strong practical knowledge of validation methodologies, including qualification activities such as DQ, IQ, OQ and PQ.
• Experience working with cGMP, GxP, GAMP and relevant quality systems, with an understanding of European and FDA regulatory expectations.
• Strong analytical and problem-solving skills, with the ability to break down complex technical issues into clear, practical actions.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across Quality Assurance, Engineering and Manufacturing.
• Strong organizational and time-management skills, with the ability to manage multiple assignments while maintaining high quality standards.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.