Job Title:
System Validation Specialist
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Key Responsibilities:
* Develop and author Computer System Validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Execute validation protocols and document results in accordance with company SOPs and regulatory guidelines.
* Perform risk assessments and impact analyses for computerized systems.
Requirements:
* Education: Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field.
* Experience: Minimum 3+ years in Computer System Validation within a regulated environment (pharmaceutical, biotech, or medical devices preferred) and hands-on experience writing and executing validation protocols (IQ/OQ/PQ).
* Technical Skills: Strong understanding of GAMP 5, 21 CFR Part 11, and Annex 11 compliance requirements; familiarity with ERP, LIMS, MES, or other Gx P systems.
* Soft Skills: Excellent documentation and communication skills; strong attention to detail and ability to work under strict timelines.
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Why this role?
This position requires the ability to analyze complex systems and identify areas for improvement. It demands excellent analytical and problem-solving skills as well as the ability to effectively communicate technical information to both technical and non-technical audiences.