Computer System Validation Engineer
Responsibilities :
- Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
- Author, review and / or approve applicable CSV documentation.
- Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.
- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
- Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required).
- Other related duties as assigned.
Requirements :
- Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
- Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts IQ / OQ / PQ or equivalent , Summary Reports, Trace Matrices, SOPs, etc.)
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding teamwork, client focus, verbal and written communication.
- Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they 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 (i.e. ServiceNow).
- Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
- Strong technical and problem-solving skills and the ability to work independently.
- Demonstrated success working in a high-performing, business results-driven environment.
- Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
- Must have experience with Computer system validation of MES.
- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
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