CSV Engineer / Validation Engineer (Offshore) - 5287

As a CSV Engineer / Validation Engineer at Verista, you will be responsible for executing validation deliverables on Advantive’s Infinity QS system. Your role will involve following established protocols, documenting results according to Good Documentation Practices, and resolving any issues encountered during testing. This position is critical for ensuring that our solutions meet industry standards and contribute positively to life sciences clients.

To qualify for the CSV Engineer / Validation Engineer position at Verista, candidates typically need a background in life sciences, engineering, or a related field. Experience in computer system validation and familiarity with Good Documentation Practices are essential. Strong problem-solving skills and the ability to follow SOPs are also crucial for success in this role.

Verista provides a comprehensive benefits package for CSV Engineers, including competitive salary, performance incentives, medical and dental insurance, life insurance, and a 401(k) retirement plan with employer matching. Additional perks include tuition reimbursement, paid parental leave, and various team social activities that promote a fun and engaging work culture.

Verista is committed to the professional growth of its employees, particularly CSV Engineers. We offer continuous learning opportunities, mentorship programs, and the chance to work on various challenging projects in the life sciences industry. Employees are encouraged to acquire new skills and learn from their experiences, enhancing their expertise and career progress.

The CSV Engineer / Validation Engineer role at Verista primarily involves working India hours. However, flexibility is required as you may participate in update meetings during US morning hours and may also work on weekends if necessary to meet project goals.

Yes, Verista is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment where all employees have the opportunity to thrive. All qualified applicants will receive consideration for employment regardless of race, gender, age, or background.

At Verista, documentation is a critical aspect of the CSV Engineer / Validation Engineer role. You'll be expected to follow Good Documentation Practices, ensuring all validation tests and issues are meticulously recorded. This process not only maintains compliance but also supports the organization’s dedication to delivering high-quality solutions to our life sciences clients.

In your response, focus on specific projects you've worked on involving computer system validation. Mention methodologies you've utilized, the types of systems you've validated, and the impact of your work on compliance and quality standards.

Discuss your approach to maintaining clear, accurate documentation. Explain how you ensure compliance with Good Documentation Practices, organize records, and address any discrepancies or issues during the validation process.

Share a specific example that highlights your problem-solving skills. Emphasize your analytical thinking, collaboration with team members, and how you communicated challenges and solutions to stakeholders effectively.

Talk about your understanding of regulatory requirements and industry standards that affect computer system validation. Detail a systematic approach you follow to ensure compliance throughout the validation lifecycle.

Explain your methods for prioritizing tasks, such as assessing project requirements, deadlines, and potential risks. Demonstrate an understanding of project management principles and the ability to adjust priorities as needed.

Highlight the importance of collaboration in validation projects. Discuss how you engage with team members, share knowledge, and contribute to a positive team environment that fosters successful outcomes.

Provide an example of a Standard Operating Procedure (SOP) relevant to validation that you've followed. Explain its significance in your work and how you've contributed to adherence or improvement of the SOP.

Mention specific validation tools and software relevant to the life sciences industry, discussing your experience and familiarity with them. This could include electronic validation tools, data management software, or documentation systems.

Outline strategies you use for effective time management and project coordination. Discuss communication points, progress tracking, and how you motivate team members to perform efficiently under tight deadlines.

Share your passion for validation and the impact it has on the life sciences industry. Discuss how your alignment with Verista’s mission to improve lives drives your work and inspires you to grow in this field.