Computer Systems Validation Engineer

Job Summary

Supporting IT compliance and validation initiatives, the full-time Computer Systems Validation Engineer will execute computer system validation activities, assist with IT compliance programs, and participate in regulatory audits while working onsite in Devens, MA.

Key responsibilities

• Execute assigned computer system validation (CSV) and IT compliance activities aligned with team objectives
• Support the implementation of CSV processes and assist in analyzing process deficiencies under senior staff direction
• Participate in regulatory audits and inspections, generating timely responses to audit observations

Required qualifications

• Bachelor's degree in Engineering, Science, Information Technology, or a related field with 1-3 years of relevant experience in Compliance and CSV
• Working knowledge of regulatory computer system validation requirements, including FDA and EMA guidelines
• Experience supporting quality systems, risk management, and deviation management in a regulated environment
• Developing ability to represent the department before stakeholders and management
• Willingness to support interactions with regulatory agencies under senior staff guidance