CSV Specialist

Lonza, a global leader in life sciences, is seeking a skilled CSV Specialist to join our team in Geleen. As a CSV Specialist, you will play a crucial role in Computerized System Validation activities and be a Subject Matter Expert within our Qualification and Validation Team.

• Participate in all Computerized System Validation activities, including Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, and more.
• Generate and execute User Requirements, Design Specification, Functional Specification, and Traceability Matrix, as well as produce Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs to meet 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP requirements.
• Develop CSV Gap Assessments and Remediation Plans, applying risk management principles.
• Support regulatory and client audits as a CSV subject matter expert.
• Identify efficiencies in the CSV program approach, apply lessons learned, and stay informed of industry regulatory changes.
• Perform assigned Quality Systems activities, including Document Management system, Change Control, Non Conformities, and CAPA's.
• Write and/or revise procedures applicable to CSV activities.
• Support the Engineering group to prepare the validation, requalification, and maintenance program.

• Bachelor degree or equivalent in a relevant subject area.
• Demonstrable experience within CSV in a GMP environment, with an excellent understanding of good documentation practices, data integrity, and ALCOA++.
• Knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5.
• Strong planning skills and self-motivated, able to work autonomously.
• Business-level fluency in English; other languages are nice to have but not required.

At Lonza, we respect and protect our people and our environment. We offer the satisfaction that comes with improving lives all around the world and making a meaningful difference.