CSV Engineer

Azzur Group is on a mission to support life science companies by ensuring compliance and excellence in operational practices. We are seeking a dedicated CSV Engineer to join our growing team. The ideal candidate will play a crucial role in validating computerized systems to meet regulatory standards while optimizing processes within the pharmaceutical and biotechnology sectors.

Key Responsibilities:

• Develop and execute validation documentation, including protocols and reports, for computerized systems in compliance with industry regulations.
• Collaborate with cross-functional teams to assess system requirements and ensure they meet GxP, GDP, GAMP, and 21 CFR Part 11 standards.
• Conduct risk assessments and create strategies to mitigate potential non-compliance risks.
• Perform hands-on testing and create validation testing scripts to confirm system functionality.
• Maintain documentation integrity and manage change controls effectively.
• Communicate project status, issues, and solutions to stakeholders professionally and clearly.
• Provide guidance and training on validation processes and best practices within the organization.
• Stay current with industry regulations and technologies to drive continuous improvement in validation practices.

Requirements

Qualifications:

• Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
• A minimum of 5-8 years of experience in Computer Systems Validation (CSV) within the pharmaceutical, biotech, or healthcare industries.
• Strong understanding of validation principles and regulatory requirements, including 21 CFR Part 11 and GxP.
• Proficiency in writing and reviewing validation documentation.
• Excellent analytical skills with a keen eye for detail.
• Strong problem-solving abilities and effective communication skills.
• Ability to work collaboratively in a team environment and manage multiple projects simultaneously.
• Relevant certifications, such as Certified Software Quality Engineer (CSQE), are a plus.