Ben Shanahan jobs

Overview

We are seeking a CSV Engineer to join our team on a 12-month contract. The successful candidate will be responsible for ensuring compliance of computer systems within a GMP-regulated environment. This is an exciting opportunity to contribute to cutting-edge biopharmaceutical manufacturing.

Key responsabilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for computerized systems.
• Ensure compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and other regulatory standards.
• Conduct risk assessments and impact analyses on computer systems.
• Maintain validation documentation and support audits.
• Collaborate with cross-functional teams including Quality, IT, and Manufacturing.
• Support system upgrades, troubleshooting, and continuous improvement initiatives.

Requirments:

• Bachelor's or Master's degree in Engineering, Computer Science, or a related field.
• 3+ years of experience in computer system validation within a pharmaceutical or biologics environment.
• Strong knowledge of GMP regulations, FDA 21 CFR Part 11, and data integrity principles.
• Experience with LIMS, MES, ERP, SCADA, and other automated systems is a plus.
• Excellent problem-solving, documentation, and communication skills.