Job Title: Dedicated CSV Engineer
The company is seeking a skilled CSV Engineer to join an expanding team for a leading Pharmaceutical company in Cork. As a CSV Engineer, you will play a crucial role in ensuring the quality and compliance of computer systems within the organization.
Daily Responsibilities:
• Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments).
• Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP).
• Authoring, reviewing, and/or approving system change, configuration management and supporting documentation.
• Preparing for and participating in external/internal computer system/software audits. Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls.
Requirements:
• A Bachelor's degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech).
• Validation experience with ERP, MES, LIMS, and Quality Systems,
• Strong knowledge of computerized system development life cycle.
This is a 12 month contract position, with hourly rates dependent on experience. If you are a motivated and detail-oriented CSV Engineer looking for your next challenge, please consider this opportunity.