We are seeking a skilled Computer System Validation (CSV) Specialist to support a fully onsite project with one of our key clients. The ideal candidate will have strong experience in validating GxP-regulated systems, ensuring compliance with 21 CFR Part 11, EU Annex 11, and applicable FDA and international regulations.
Responsibilities:
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Develop, review, and execute validation deliverables including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Traceability Matrices, Test Protocols (IQ/OQ/PQ), and Summary Reports.
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Ensure systems are validated in accordance with client and regulatory requirements.
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Support change control processes and manage deviations and CAPAs related to computer systems.
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Collaborate with QA, IT, and business stakeholders to gather requirements and maintain validation documentation.
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Conduct periodic reviews and revalidations as needed.
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Participate in audits and inspections, providing validation documentation as required.
Requirements:
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Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
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3+ years of hands-on CSV experience in regulated industries (pharmaceutical, biotechnology, or medical device preferred).
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Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.
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Experience with validation of software systems such as MES, Data Historian, ERP, or SCADA preferred.
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Excellent written and verbal communication skills.
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Ability to work independently and onsite at client facilities.
Preferred Qualifications:
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Experience working in a highly regulated environment.
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Familiarity with validation in cloud-based and hybrid system environments.
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Knowledge of SDLC and risk-based validation approaches.