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Computer System Validation Specialist

2 months ago

Bothell, Washington, United States Integrated Resources Full time

Integrated Resources is seeking a skilled Computer System Validation (CSV) Engineer to join our team. The ideal candidate will have a strong background in computer system validation, with experience in leading and executing validation activities for GxP electronic systems and applications. The CSV Engineer will work closely with Business Owners, Technical Owners, and Quality to create and manage validation deliverables throughout the validation lifecycle. Key responsibilities include ensuring routine tasks supporting validation of electronic systems and applications are documented in accordance with relevant Client procedures and regulations. This includes coordination of system validation periodic reviews and audit activities, as well as support of computer system validation efforts for new system implementations and changes to existing systems. The successful candidate will have a strong knowledge of MES systems (e.g. Emerson Syncade) and ERP systems (e.g. SAP or Oracle), as well as experience in developing CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, SOPs, etc.). Additionally, the candidate should have a solid understanding of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices. The ideal candidate will be able to effectively communicate with both technical and non-technical team members, possess strong interpersonal skills, and have a strong technical and problem-solving background. The CSV Engineer will be responsible for leading routine CSV lifecycle activities, coordinating with system owners and Quality in accordance with company procedures and regulatory requirements. The candidate should have a Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience. The successful candidate will be able to work independently and as part of a high-performing team, with a strong focus on business results. If you are a motivated and detail-oriented professional with a passion for computer system validation, we encourage you to apply for this exciting opportunity.