What are the responsibilities and job description for the CSV Lead Consultant position at Shimento, Inc.?
Job Details
CSV Consultant
San Francisco, CA
Job Description:
We are seeking a CSV Automation Engineer with expertise in Computer System Validation (CSV), system integration, and compliance within the pharmaceutical industry. The role involves validating automation, MES, LIMS, and manufacturing systems while ensuring regulatory compliance with FDA 21 CFR Part 11, GAMP 5, and data integrity (ALCOA ).
Key Responsibilities:
- Develop and execute CSV protocols (IQ/OQ/PQ) for automated systems.
- Ensure compliance with GxP, FDA, and regulatory standards.
- Integrate and validate SCADA, MES, LIMS, ERP, and laboratory instruments.
- Perform risk assessments, audit trails, and system troubleshooting.
- Support regulatory audits and maintain validation documentation.
Qualifications:
- 5 years in CSV, automation, and integration in a pharma/biotech environment.
- Experience with SCADA, MES (Werum PAS-X), LIMS (LabWare, SampleManager), and ERP (SAP).
- Strong knowledge of GAMP 5, 21 CFR Part 11, ALCOA principles.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
