System Validation (Csv) Engineer / Specialist

System Validation (CSV) Engineer / Specialist
Location: Remote

Job Summary:
We are seeking a detail-oriented Computer System Validation (CSV) Engineer with hands-on experience in validating computerized systems in regulated environments. The ideal candidate should have strong knowledge of GAMP 5 guidelines, experience working with ERP systems (e.g., Epicor, SAP, Oracle), and validation of custom-built software applications.

Key Responsibilities:
•    Perform end-to-end Computer System Validation activities in compliance with regulatory requirements.
•    Develop and review validation deliverables such as:
•    Validation Plans (VP)
•    User Requirements Specifications (URS)
•    Functional Specifications (FS) / Design Specifications (DS)
•    Risk Assessments (RA)
•    IQ/OQ/PQ protocols and reports
•    Traceability Matrix (RTM)
•    Apply risk-based validation approach as per GAMP 5 guidelines.
•    Execute validation protocols and document results, deviations, and discrepancies.
•    Perform validation for:
•    ERP systems (e.g., inventory, quality, manufacturing modules)
•    Custom-developed applications
•    Interfaces and data integrity workflows
•    Support software lifecycle activities including change control, deviation management, and periodic review.
•    Ensure compliance with applicable regulations such as 21 CFR Part 11, Annex 11, and internal quality procedures.
•    Collaborate with cross-functional teams (QA, IT, Development, Business stakeholders).
•    Participate in audits and provide necessary documentation support.

Required Skills & Qualifications:
•    Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field.
•    2–6 years of experience in Computer System Validation.
•    Strong understanding of GAMP 5 and validation lifecycle (V-model).
•    Hands-on experience with ERP systems validation (e.g., Epicor, SAP, Oracle).
•    Experience validating custom software / automated systems.
•    Knowledge of:
•    Risk management principles
•    Data integrity requirements
•    Software development lifecycle (SDLC)
•    Familiarity with documentation tools (e.g., Excel, ALM tools, JIRA, Azure DevOps, etc.).
•    Strong analytical, documentation, and communication skills.