What are the responsibilities and job description for the CSV Engineer position at KKR Consulting?
About the Company:
We are seeking Computer System Validation (CSV) Engineers for a long-term contract opportunity based in Indianapolis, IN. This role is ideal for professionals with 5–10 years of experience in CSV across various systems. We are open to reviewing 2–4 qualified profiles.
About the Role:
Author and execute validation documentation in alignment with data integrity and regulatory compliance standards. Perform CSV activities for SCADA, automation systems, and lab systems. Ensure systems comply with 21 CFR Part 11, GAMP 5, and other applicable guidelines. Support audits, risk assessments, and remediation plans related to computerized systems. Collaborate with cross-functional teams including QA, IT, Engineering, and Laboratory Operations.
Responsibilities:
- Author and execute validation documentation in alignment with data integrity and regulatory compliance standards.
- Perform CSV activities for SCADA, automation systems, and lab systems.
- Ensure systems comply with 21 CFR Part 11, GAMP 5, and other applicable guidelines.
- Support audits, risk assessments, and remediation plans related to computerized systems.
- Collaborate with cross-functional teams including QA, IT, Engineering, and Laboratory Operations.
Qualifications:
5–10 years of hands-on experience in Computer System Validation. Strong understanding of data integrity principles and documentation best practices. Demonstrated experience in validating SCADA systems, automated manufacturing systems, and laboratory systems. Familiarity with FDA, EMA, and other regulatory requirements for computerized systems.
Preferred Skills:
- Experience in regulated environments such as pharmaceuticals, biotech, or medical devices.
- Excellent documentation, communication, and problem-solving skills.
