Senior QA Validation Lead — cGMP, Life Sciences

Lonza Group

Geleen

On-site

EUR 54,000 - 76,000

Full time

3 hours ago
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Benefits offered by this job

Agile culture
Ethical workplace
Competitive pay
Role-based benefits
Continuous improvement opportunities
International standardization

Job summary

Lonza in Geleen, Netherlands, is seeking a Sr. QA Validation Specialist to help ensure facilities, utilities and equipment meet quality and regulatory standards.

The role is fully site-based and requires collaboration with Engineering, Manufacturing and Quality Assurance to support compliant medicines production. You will oversee qualification and validation activities (DQ/IQ/OQ/PQ), review validation documents, manage deviations and changes, and provide cross-functional QA support to drive

Qualifications

  • 5–10 years of relevant experience in validation or quality assurance within a regulated manufacturing environment.
  • Strong knowledge of validation methodologies (DQ/IQ/OQ/PQ) and cGMP/GxP.

Responsibilities

  • Oversee qualification and validation activities for equipment, facilities and utilities, ensuring regulatory compliance.
  • Review and approve validation documentation, including URs, validation plans, design/qualification docs, commissioning docs and site acceptance testing.
  • Ensure traceability of requirements through the validation lifecycle and support periodic reviews of validated assets.
  • Manage validation deviations and changes with proper documentation and corrective actions.
  • Provide QA support to Engineering, Manufacturing and Technical Services teams to uphold quality standards.

Skills

Validation
QA
cGMP

Education

Engineering or Life Science degree

Job description

Lonza in Geleen, Netherlands, is seeking a Sr. QA Validation Specialist to help ensure facilities, utilities and equipment meet quality and regulatory standards.

The role is fully site-based and requires collaboration with Engineering, Manufacturing and Quality Assurance to support compliant medicines production. You will oversee qualification and validation activities (DQ/IQ/OQ/PQ), review validation documents, manage deviations and changes, and provide cross-functional QA support to drive

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