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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