CSV Specialist

4 weken geleden

Geleen, Limburg, Nederland Lonza Voltijd
Join Our Team as a CSV Specialist

Lonza is a global leader in life sciences, operating across three continents. We're seeking a talented CSV Specialist to join our team in Geleen, Netherlands.

About the Role

This specialized role will focus on Computerized System Validation activities, making you a highly important Subject Matter Expert within our wider team. You'll have the opportunity to take on a niche position within a dynamic and diverse group at Lonza, offering excellent potential for growth and development.

Key Responsibilities
  • Involved in all Computerized System Validation activities, including Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, and more.
  • Generates and executes User Requirements, Design Specification, Functional Specification, and Traceability Matrix.
  • Develops CSV Gap Assessments and Remediation Plans, applying risk management principles.
  • Supports regulatory and client audits as CSV subject matter expert.
  • Identifies efficiencies in the CSV program approach and applies lessons learned.
  • Performs assigned Quality Systems activities, including Document Management system, Change Control, Non Conformities, and CAPA's.
  • Writes and/or revises procedures applicable to CSV activities.
Requirements
  • 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.
About Lonza

Every day, Lonza's products and services have a positive impact on millions of people. We respect and protect our people and our environment. Our success is not just about achieving business results, but also about doing it ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world.

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