Validation Engineer (CSV, CSA, Quality, Technology Quality, Computer Systems Validation) in Somerville

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Job Description

Job Details:

Global Pharmaceutical Company

Role - Sr. CSV Engineer

Location - Raritan, NJ - Hybrid (2-3 days onsite, the rest remote)

Pay rate available for w2 and c2c

experience working with divestitures, mergers, and acquisitions is a huge plus

experience managing offshore and guiding junior validation engineers and teams in a plus

experience with jira, qtest, service now/iris, saas/paas applications, and gxp/erp applications is a huge plus

Job Details:

• 7+ years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area

• Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM, Data Flow Map, Change Controls etc.

• Developing validation strategy for projects

• Providing audit support and support Application Lifecycle Management

• Managing/guiding/overseeing periodic checks

• Ability to guide cross-functional teams and mentor junior staff

• Broad experience in Computer System Validation (CSV) and testing

• Acquainted with Good Clinical Practices (GCP) regulatory requirements and FDA 21 CFR Part 11

• Clear written and verbal communication, especially for technical documentation

• Acquainted with both the agile and waterfall software development methodology

• Solid understanding of the fundamentals of iterative and incremental software development

• Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems

• Skilled in project planning, execution and minimal rework strategies

• Capable of risk identification and mitigation, especially in regulated environments

• Strong Analytical and Problem solving

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