Computerized System Validation Specialist
1 dag geleden
We are seeking a highly skilled CSV Specialist to join our team at Lonza in Geleen.
This specialized role will focus on Computerized System Validation activities and is a highly important Subject Matter Expert within the wider team.
The CSV Specialist will be involved in all Computerized System Validation activities including facilities, utilities, validation life cycle, execution, technical documentation, process, GAP analysis, risk assessment, among others.
Key responsibilities include:
- Generating and executing user requirements, design specifications, functional specifications, and traceability matrices.
- 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.
- Developing CSV gap assessments and remediation plans with a focus on risk management principles.
- Supporting regulatory and client audits as a CSV subject matter expert.
- Identifying efficiencies in the CSV program approach and applying lessons learned.
- Performing assigned quality systems activities, including document management, change control, non-conformities, and CAPAs.
- Writing and/or revising procedures applicable to CSV activities.
The ideal candidate will have a bachelor's degree in a relevant subject area, demonstrable experience within CSV in a GMP environment, and excellent understanding of good documentation practices, data integrity, and ALCOA++.
The CSV Specialist must have knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5, strong planning skills, and self-motivation, with the ability to work autonomously.
Business-level fluency in English is required; other languages are a plus but not necessary.
At Lonza, we are committed to improving lives all around the world through our work in life sciences. If you are passionate about making a meaningful difference, we encourage you to apply for this exciting opportunity.
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Computerized System Validation Specialist
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