Computer System Validation (CSV) Engineer

Computer System Validation (CSV) Engineer

• Greater Boston - South Shore
• 3-6 Month Contract (High Potential for Long-term Extension)
• Compensation: open & flexible
• No Sponsorship / No Relocation

Job Description:
We are seeking a Computer System Validation (CSV) Engineer to support our pharmaceutical client's validation initiatives. The ideal candidate will play a critical role in ensuring compliance with industry regulations (FDA, GxP) by validating software systems and processes in a regulated environment.

Key Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for computerized systems in line with regulatory requirements.
• Own and drive GMP and Automation projects
• Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP standards.
• Collaborate with cross-functional teams, including QA, IT, and system owners, to manage validation activities.
• Perform risk assessments and document validation deliverables such as Validation Plans, Test Scripts, and Summary Reports.
• Troubleshoot validation issues and recommend corrective actions.
• Maintain accurate records and documentation for audits and regulatory inspections.

Qualifications:

• Experience in computer system validation within the pharmaceutical or biotech industry.
• Strong knowledge of FDA regulations and GxP compliance.
• Familiarity with validation tools and software systems used in a regulated environment.

Preferred:

• Experience with Lab Systems, ERP systems, LIMS, or other pharmaceutical software.
• Knowledge of data integrity principles and audit readiness.

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