What are the responsibilities and job description for the Validation Engineer - Full Time position at Bluegrass Stream?
Computer Systems Validation Engineer
Role And Responsibilities
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.
- 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.