Rockstone Engineering is seeking a CSV Engineer to manage the Computerized System Validation (CSV) lifecycle for critical systems in the life sciences industry. You’ll ensure compliance with GxP, FDA, and EMA regulations while enabling operational excellence for cutting-edge pharmaceutical and biotech facilities.

• Develop and execute validation protocols (IQ, OQ, PQ) for computerized systems.
• Manage the validation lifecycle for systems such as MES, DeltaV, and ERP platforms.
• Prepare and review CSV documentation, including risk assessments, validation plans, and reports.
• Ensure compliance with industry standards, including 21 CFR Part 11 and Annex 11.
• Collaborate with cross-functional teams to deliver compliant and efficient computerized systems.
• Troubleshoot and resolve validation issues, ensuring timely project delivery.

• 3+ years of experience in Computerized System Validation within the pharmaceutical or biotech industry.
• Strong understanding of GAMP 5 and regulatory standards (21 CFR Part 11, Annex 11).
• Hands-on experience with systems such as MES, DeltaV, and IT infrastructure.
• Excellent analytical, documentation, and communication skills.
• Bachelor’s degree in Engineering, Computer Science, or a related field.

• Opportunities to work with advanced automation technologies.
• Career growth in a collaborative, innovative environment.
• Competitive salary and comprehensive benefits.