CSV Engineer

About Us: Azzur Group is a premier consulting firm dedicated to providing exceptional solutions in Computer Systems Validation (CSV) for the life sciences sector. Our mission is to ensure that our clients' systems and processes comply with stringent regulatory standards and operate at peak efficiency. Join our expert team and help drive innovation and compliance in an industry that shapes the future of health and medicine.

Position Overview: We are looking for a detail-oriented and experienced CSV Engineer to join our team. The CSV Engineer will be responsible for ensuring that computer systems and software used in regulated environments meet compliance requirements and operate according to user specifications. The ideal candidate will have a strong background in CSV, an understanding of industry regulations, and the ability to manage validation projects from start to finish.

Key Responsibilities:

• Validation Documentation and Execution:
• Develop, review, and execute validation plans, protocols, and reports for computer systems and software in regulated environments.
• Ensure documentation and activities comply with FDA, EMA, and other relevant regulatory standards (e.g., 21 CFR Part 11, GxP).
• Conduct risk assessments to identify and mitigate potential validation and compliance issues.
• Review and analyze system design and specifications to ensure they meet validation requirements.
• Validate electronic records and signatures to ensure integrity and security.
• Manage validation projects, including planning, execution, and reporting, to ensure timely and accurate delivery.
• Communicate project status, issues, and risks to clients and internal teams.
• Provide technical expertise and guidance to clients and project teams throughout the validation process.
• Develop and implement best practices for CSV and contribute to the creation of standard operating procedures (SOPs).
• Stay updated on industry trends, regulatory changes, and technological advancements to ensure compliance and improve validation practices.
• Work closely with clients to understand their needs and requirements, providing expert advice and solutions.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and regulatory compliance, to achieve project goals.

Requirements

Qualifications:

• Education:
• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or a related field. Advanced degrees are a plus.
• Experience:
• Minimum of 3-5 years of experience in Computer Systems Validation within the pharmaceutical, biotechnology, or medical device industries.
• Proven experience with validation of computerized systems, software applications, and electronic records.
• Skills:
• In-depth knowledge of CSV principles, regulatory requirements, and industry standards.
• Proficiency in writing and reviewing validation documentation, including validation plans, protocols, and reports.
• Strong analytical and problem-solving skills with a keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to work effectively with clients and team members.

Certifications:

• Relevant certifications (e.g., Certified Software Quality Engineer (CSQE)) are preferred but not required.

Why Join Us:

• Competitive salary and comprehensive benefits package.
• Opportunity to work on impactful projects with leading industry clients.
• Professional development and career growth opportunities.
• Supportive work environment that values work-life balance and employee well-being.

Application Process: To apply, please submit your resume and a cover letter detailing your qualifications and experience related to the CSV Engineer role to [application email/portal].

Azzur Group is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.