JVM Global Inc
Job Description
JVM Global
is a consulting partner to regulated life sciences companies—bringing deep technical, validation, and quality expertise to every stage of the product lifecycle. We help pharmaceutical, biotech, and medical device organizations overcome complexity, accelerate timelines, and stay audit-ready. We are currently seeking to identify Computer System Validation (CSV) Engineers with cGMP experience for both immediate and future consulting project needs. This is a pipeline opportunity to support our ongoing client engagements. Qualified applicants will be contacted as relevant projects arise. Candidates may reside anywhere in the United States but must be authorized to work for any U.S. employer without the need for visa sponsorship. Qualifications Bachelor’s degree in computer science, engineering, life sciences, or a related technical field Experience validating GxP systems in pharma, biotech, or medical device environments Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and other relevant FDA/ICH guidance Hands-on experience authoring and executing validation deliverables including risk assessments, validation plans, IQ/OQ/PQ protocols, and traceability matrices Experience with systems such as LIMS, ERP, MES, QMS, PLC/SCADA, or laboratory instrumentation software is preferred Understanding of data integrity principles, audit trails, and ALCOA+ Strong documentation and technical writing skills Excellent communication skills and ability to collaborate cross-functionally Responsibilities Responsibilities will vary depending on the project and client needs. Typical responsibilities may include: Authoring, reviewing, and executing validation deliverables for GxP computer systems Performing risk assessments and ensuring validation approaches meet regulatory and client requirements Supporting implementation and lifecycle management of validated systems Ensuring compliance with 21 CFR Part 11, GAMP 5, and data integrity best practices Collaborating with Quality, IT, and Business users to ensure requirements are met and appropriately tested Supporting audit readiness and remediation activities related to system validation Providing guidance on software change controls, configuration management, and system documentation Work Requirements This is a U.S.-based consulting role requiring 25–75% travel, depending on project location and client assignment Flexibility for on-site client work is essential Interested? If you meet the qualifications and are excited about supporting meaningful work in the life sciences industry, we invite you to submit your application. We look forward to connecting with you. JVM Global
is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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is a consulting partner to regulated life sciences companies—bringing deep technical, validation, and quality expertise to every stage of the product lifecycle. We help pharmaceutical, biotech, and medical device organizations overcome complexity, accelerate timelines, and stay audit-ready. We are currently seeking to identify Computer System Validation (CSV) Engineers with cGMP experience for both immediate and future consulting project needs. This is a pipeline opportunity to support our ongoing client engagements. Qualified applicants will be contacted as relevant projects arise. Candidates may reside anywhere in the United States but must be authorized to work for any U.S. employer without the need for visa sponsorship. Qualifications Bachelor’s degree in computer science, engineering, life sciences, or a related technical field Experience validating GxP systems in pharma, biotech, or medical device environments Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5, and other relevant FDA/ICH guidance Hands-on experience authoring and executing validation deliverables including risk assessments, validation plans, IQ/OQ/PQ protocols, and traceability matrices Experience with systems such as LIMS, ERP, MES, QMS, PLC/SCADA, or laboratory instrumentation software is preferred Understanding of data integrity principles, audit trails, and ALCOA+ Strong documentation and technical writing skills Excellent communication skills and ability to collaborate cross-functionally Responsibilities Responsibilities will vary depending on the project and client needs. Typical responsibilities may include: Authoring, reviewing, and executing validation deliverables for GxP computer systems Performing risk assessments and ensuring validation approaches meet regulatory and client requirements Supporting implementation and lifecycle management of validated systems Ensuring compliance with 21 CFR Part 11, GAMP 5, and data integrity best practices Collaborating with Quality, IT, and Business users to ensure requirements are met and appropriately tested Supporting audit readiness and remediation activities related to system validation Providing guidance on software change controls, configuration management, and system documentation Work Requirements This is a U.S.-based consulting role requiring 25–75% travel, depending on project location and client assignment Flexibility for on-site client work is essential Interested? If you meet the qualifications and are excited about supporting meaningful work in the life sciences industry, we invite you to submit your application. We look forward to connecting with you. JVM Global
is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
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