CSV Engineer in Texas

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...

Summary: BioPharma Consulting JAD Group is seeking a talented and experienced Computer System Validation (CSV) Senior Engineer to join our team. As a CSV Senior Engineer, you will play a critical role in ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will lead and execute computer system validation activities and provide expertise in CSV best practices.

Functions: 

• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others. 

• Plan and organize validation...

Summary: BioPharma Consulting JAD Group is seeking a Computer System Validation (CSV) Engineer III to join our team. As a CSV Engineer III, you will be responsible for ensuring compliance with regulatory requirements and industry standards for computerized systems used in pharmaceutical manufacturing processes. You will work closely with cross-functional teams to plan and execute computer system validation activities and ensure the integrity of data generated by these systems.

Functions: 

• Generate, obtain approvals, and execute validation deliverables for computerized systems and relevant infrastructure, including Validation Plans, Requirements Specification, Risk Assessments, Installation/Operational Qualifications, Traceability Matrices, and Validation Final Reports, ensuring documents meet regulatory and procedural requirements of 21 CFR Part-11, Annex-11 Data Integrity and GAMP5 among others. 

• Plan...

Verista’s 600 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do...