CSV Validation Engineer [Contract W2]

Job Title: CSV Validation Engineer

Location: Lebanon, Indiana

Minimum years of experience: 8 Years

Mandatory skills:

Demonstrated experience in computer systems validation (CSV) for automation and control systems in a pharmaceutical/GMP-regulated environment.

Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches.

Experience with 21 CFR Part 11 compliance, including assessment of electronic records, electronic signatures, and audit trail requirements.

Proficiency in developing validation deliverables across SDLC Life cycle.

Experience with DCS, PLC/HMI, and/or historian systems in a manufacturing environment.

Strong understanding of FDA and EMA regulatory expectations for computerized system validation.

Thanks and regards

paul

paul@ampstek.com