CSV Validation Engineer
3 dagen geleden
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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