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Computer Systems Validation Specialist
2 months ago
We are seeking a highly skilled Computer Systems Validation Engineer to join our team at Katalyst Healthcares & Life Sciences. As a CSV Engineer, you will play a critical role in ensuring the validation of our electronic systems and applications meets regulatory requirements.
Key Responsibilities- Lead routine CSV lifecycle activities, including system periodic validation and audit trail/user access reviews, in accordance with company procedures and regulatory requirements.
- Author, review, and/or approve applicable CSV documentation, including validation plans, requirements, specifications, assessments, test scripts, and summary reports.
- Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures.
- Support health authority inspections as a subject matter expert for routine CSV lifecycle activities.
- Strong knowledge of MES systems (e.g., Emerson Syncade) and ERP systems (e.g., SAP or Oracle).
- Familiarity with development of CSV documentation, including validation plans, requirements, specifications, assessments, test scripts, and summary reports.
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, including teamwork, client focus, verbal, and written communication.
- Knowledge of industry-standard Quality and Compliance methodology to ensure IT systems deliver intended performance and meet regulatory requirements.
- Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
- Knowledge of IT service management platforms to support change IT operational events (e.g., ServiceNow).
- Knowledge and exposure to Business Quality Management Systems (e.g., Veeva).
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
