Senior C&Q Engineer

As a Senior C&Q Engineer at Maravai LifeSciences, you will provide critical guidance in the development of User Requirement Specifications, System Impact Assessments, and risk assessments. You will also oversee qualification activities, mentor cross-functional teams, manage documentation related to equipment lifecycle, and ensure compliance with industry standards such as ISO, GMP, and 21 CFR Part 11.

To qualify for the Senior C&Q Engineer role at Maravai LifeSciences, candidates should possess a Bachelor's degree in a scientific discipline, along with a minimum of 5 years of experience in the life sciences industry. Experience in equipment qualification and computer system validation is essential, and knowledge of FDA regulated biotechnology or drug validation requirements will be highly advantageous.

The Senior C&Q Engineer at Maravai LifeSciences ensures compliance by developing and managing documentation that meets rigorous industry standards. This includes conducting thorough audits, managing change controls, and performing risk assessments to ensure that all processes adhere to guidelines such as ISO, GMP, and 21 CFR Part 11.

The Senior C&Q Engineer plays a significant role in project success at Maravai LifeSciences by providing leadership and oversight in qualification activities. By mentoring teams, managing documentation, and ensuring compliance with industry standards, the engineer helps drive the successful execution of projects that contribute to groundbreaking advancements in biotechnology.

A Senior C&Q Engineer at Maravai LifeSciences can expect a highly competitive salary, long-term incentives in the form of company equity, and a robust benefits package that includes comprehensive medical plans, retirement contributions, and additional optional benefits. The work environment is designed to be inclusive and supportive of personal growth.

When discussing methodologies for equipment qualification, highlight specific approaches such as GAMP-5 and Good Engineering Practices (GEP). Emphasize your experience with documentation, risk assessments, and validation processes that ensure compliance with FDA regulations.

Share examples of your involvement in developing User Requirement Specifications. Discuss how you ensure that URS captures all necessary functional requirements and how you work with cross-functional teams to achieve consensus on specifications that meet regulatory compliance.

Describe your systematic approach to risk assessment. Explain how you identify potential risks, assess their impact and likelihood, and establish mitigations. Mention tools like FMEA to support your analysis and decision-making.

When addressing deviations, outline your approach to documenting the deviation, conducting root cause analysis, and implementing corrective actions. Highlight your ability to collaborate with teams to ensure compliance throughout the resolution process.

Discuss your direct experiences with computer system validation, including your knowledge of applicable regulations such as 21 CFR Part 11. Provide specific examples of projects where you conducted validations and the methodologies you employed.

Emphasize your commitment to continuous learning. Mention specific resources, networking opportunities, or professional organizations that you engage with to remain informed about trends, regulations, and best practices in the life sciences industry.

Provide a narrative about a project you successfully led, detailing your role, the challenges you faced, and the outcome. Highlight your leadership skills, innovative problem-solving techniques, and the positive impact on your organization or the broader community.

Discuss your mentoring strategies, focusing on how you encourage junior engineers to develop their skills. Highlight methods such as knowledge sharing, providing hands-on experiences, and fostering a culture of open communication and continuous improvement.

Share your techniques for fostering collaboration, such as establishing clear communication channels, setting joint objectives, and using collaborative tools. Provide examples of successful team projects to illustrate your approach.

Outline the critical factors you evaluate when reviewing technical requirement specifications, such as completeness, clarity, compliance with regulatory standards, and alignment with project goals. Highlight your attention to detail and analytical skills in this process.