CSV Validation Engineer

3 dagen geleden


Geleen, Limburg, Nederland Lonza Voltijd
CSV Specialist Job Description

Lonza, a global leader in life sciences, is seeking a talented CSV Specialist to join its Qualification and Validation Team.

This specialized role focuses on Computerized System Validation activities and is a highly important Subject Matter Expert within the wider team.

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, producing validation plans, IQ/OQ/PQ protocols, test scripts, and SOPs to meet 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP requirements.
  • 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, applies lessons learned, and stays informed of industry regulatory changes.
  • 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.
  • Supports the Engineering group to prepare the validation, requalification, and maintenance program.

Key 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.

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