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Role Overview:
- Lead CSV and CSA initiatives for regulated healthcare environments.
- Oversee validation strategies for enterprise platforms, manufacturing systems, and GxP-regulated applications.
Key Accountabilities:
- Develop and execute validation protocols including IQ, OQ, and PQ.
- Ensure compliance with FDA 21 CFR Parts 11 and 820, ISO 13485, and GAMP 5.
- Maintain validation documentation such as URS, traceability matrices, and summary reports.
Requirements:
- At least 5 years of experience in Computer System Validation in life sciences.
- Strong knowledge of risk-based validation, data integrity, and electronic records.
- Excellent analytical, problem-solving, and technical writing skills.
Benefits:
- Competitive healthcare benefits and employee support programs.
- Paid time off and potential remote-work flexibility.
- Professional development and collaboration with experienced teams across quality, engineering, and IT.
Partner Company
The company is a technology-driven organization in the healthcare and life sciences sector, focused on ensuring the safety, quality, and reliability of computerized systems used in regulated environments. It fosters a collaborative culture that values continuous improvement, professional growth, and cross-functional teamwork.