Computer Systems Validation Engineer

About the role

Join a dynamic team at Abeon Therapeutics, a leading biotechnology company focused on developing innovative therapies for unmet medical needs. We are seeking a highly skilled Computer Systems Validation Engineer to join our growing team.

Responsibilities

• Develop and maintain validation plans for computer systems used in the development and manufacturing of pharmaceutical products.
• Conduct risk assessments and ensure compliance with regulatory requirements such as FDA 21 CFR Part 11.
• Collaborate with cross-functional teams including IT, Quality Assurance, and Manufacturing to ensure seamless integration of validated systems.
• Perform system testing and validation activities according to established protocols.
• Document validation activities and maintain records in accordance with Good Documentation Practices (GDP).

Requirements

• Bachelor’s degree in Computer Science, Engineering, or a related field.
• Minimum of 3 years of experience in computer systems validation or equivalent relevant experience.
• Experience with FDA regulations and guidelines, particularly 21 CFR Part 11.
• Strong knowledge of software development lifecycle and quality assurance principles.
• Proficient in using validation tools and software like VxL, VxL-IT, or similar validation software.
• Excellent problem-solving and analytical skills.
• Ability to work independently and as part of a team.

Qualifications

• Knowledge of GAMP 5 and other industry best practices in computer systems validation.
• Experience with data integrity and security controls.
• Good understanding of pharmaceutical manufacturing processes.

Skills

• Strong programming skills in Python, Java, or C#.
• Experience with database management systems (DBMS).
• Understanding of network architecture and security.
• Good communication and interpersonal skills.

Benefits

• Competitive salary package.
• Incentive-based compensation plan.
• Flexible working hours.
• Professional development opportunities.
• Health insurance coverage.
• Employee wellness programs.

Pay

Commensurate with experience.

Schedule

Full-time, Monday through Friday.