Validation Engineer - Full Time

Computer Systems Validation Engineer Role And Responsibilities Identify and implement industry best practices through extensive network and regulatory knowledge.Risk assess systems, review change requests and test scripts, and draft protocols.Initiate and review GMP documentation revisions to ensure compliance.Lead communication and coordination between internal teams and CSV for timely completion of activities.Maintain comprehensive knowledge of policies, 21 CFR Part 11, Data Integrity, ICH Q7A, GAMP, and principles.Perform Quality Systems Management processes, including Change Control, Deviations, CAPAs, and Validation Maintenance.Participate as a Subject Matter Expert in audits and inspections.Own, revise, and maintain CSV SOPs.Mentor and train junior team members. Qualifications And Skills Bachelor’s degree in computer science, engineering, or related sciences.At least 5 years of experience with automation and computerized system validation.Minimum 2 years’ experience with Controls Automation, Process Control Systems, MES (preferably DeltaV), and Distributed Systems.Experience leading or managing projects and familiarity with CAPAs and deviations.Background in biotech, pharma, medical devices, or biologics industries.Ability to work independently and meet deadlines effectively.