Computer System Validation Engineer

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Job description

Knowledge, Skills, and Abilities:

• 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 team work, 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.

Education and Experience:

• 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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