Job Description
Job Title: Computer System Validation (CSV) Engineer
Industry: Pharmaceutical / Biotechnology
About the Role
We are seeking a skilled Computer System Validation (CSV) Engineer to support validation and compliance activities within our pharmaceutical operations. The role focuses on ensuring computerized systems meet regulatory requirements, function reliably, and comply with GxP standards.
Key Responsibilities
Develop, review, and execute Validation Plans, Test Scripts (IQ/OQ/PQ), and Traceability Matrices .
Perform risk assessments, impact analyses, and ensure system compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
Collaborate with QA, IT, Manufacturing, and Engineering teams to validate laboratory systems (LIMS, CDS, etc.), manufacturing execution systems (MES), ERP, and other GxP applications .
Document deviations, manage change control, and support system audits and regulatory inspections.
Ensure adherence to company policies, SOPs, and cGMP requirements.
Provide training and guidance on CSV processes and best practices.
Qualifications & Skills
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
Proven experience (2–7 years) in CSV, IT compliance, or Quality Assurance in the pharma/biotech sector.
Strong knowledge of GxP, cGMP, 21 CFR Part 11, GAMP 5, and data integrity principles .
Hands-on experience with validation of laboratory, manufacturing, and business systems.
Excellent documentation, problem-solving, and communication skills.
Familiarity with project management and cross-functional team collaboration.
Thanks
Suchi
suchi@vastekgroup.com
Company DescriptionVastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.
Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.
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