CSV Engineer Job Lenoir area,North Carolina USA,Engineering

Accentuate Staffing is partnering with a pharmaceutical manufacturing company who is hiring for a CSV Engineer. This is a direct hire opportunity offering competitive pay and benefits while working onsite in Lenoir, NC. The ideal candidate has strong Computer System Validation experience, knowledge of FDA/GAMP regulations, and experience supporting automated systems within regulated manufacturing environments.

Responsibilities

Execute pharmaceutical CSV validation projects including implementation of new systems, remediation of legacy systems, and re-validation activities

Develop and execute validation deliverables including Validation Master Plans, IQ/OQ/PQ protocols, summary reports, and impact assessments

Coordinate with validation, engineering, IT, and quality teams to ensure successful project execution

Lead cross-functional teams in development and execution of validation activities

Generate and review system impact assessments and critical aspect assessments

Engage end users for URS/FRS documentation generation and testing requirements

Develop and execute test scripts while supporting troubleshooting and system configuration activities

Manage multiple CSV projects utilizing project management methodologies

Support development of validation best practices aligned with current industry standards and guidelines

Ensure compliance with applicable SOPs, safety procedures, and regulatory requirements

Requirements

Bachelor’s Degree in Computer Science, Engineering, or related field

Minimum 3 years of Computer System Validation experience within a pharmaceutical or biotech environment

Strong understanding of FDA, EU compliance regulations, and GAMP guidelines related to CSV

Experience with computerized system lifecycle validation deliverables

Experience with ERP systems, EQMS systems, PLC/SCADA, DCS, laboratory instrumentation, or process automation technologies

Familiarity with off-the-shelf, configurable, and custom-developed applications

Experience with in pharmaceutical manufacturing environments preferred

Proficiency with Microsoft Office and quality systems software

Strong communication and cross-functional collaboration skills

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