CSV Engineer

Accentuate Staffing; Lenoir (NC); On-site; USD 75,000 - 95,000; Full time

Job summary

Accentuate Staffing is seeking a CSV Engineer for a pharmaceutical manufacturing company in Lenoir, NC. This direct hire opportunity offers competitive pay and benefits while requiring strong Computer System Validation experience and knowledge of FDA/GAMP regulations.

The candidate should have a bachelor's degree in a related field and a minimum of 3 years of experience within a pharmaceutical or biotech environment, including execution of validation projects and collaboration across teams.

Qualifications

• 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.

Responsibilities

• Execute pharmaceutical CSV validation projects including implementation of new systems.
• Develop and execute validation deliverables including Validation Master Plans.
• Coordinate with validation, engineering, IT, and quality teams to ensure successful project execution.

Skills

Computer System Validation

FDA/GAMP regulations

Automated systems support

Project management methodologies

Communication skills

Education

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

Tools

Microsoft Office

Quality systems software

Job description

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

1. Execute pharmaceutical CSV validation projects including implementation of new systems, remediation of legacy systems, and re-validation activities
2. Develop and execute validation deliverables including Validation Master Plans, IQ/OQ/PQ protocols, summary reports, and impact assessments
3. Coordinate with validation, engineering, IT, and quality teams to ensure successful project execution
4. Lead cross-functional teams in development and execution of validation activities
5. Generate and review system impact assessments and critical aspect assessments
6. Engage end users for URS/FRS documentation generation and testing requirements
7. Develop and execute test scripts while supporting troubleshooting and system configuration activities
8. Manage multiple CSV projects utilizing project management methodologies
9. Support development of validation best practices aligned with current industry standards and guidelines
10. Ensure compliance with applicable SOPs, safety procedures, and regulatory requirements

Requirements

1. Bachelor’s Degree in Computer Science, Engineering, or related field
2. Minimum 3 years of Computer System Validation experience within a pharmaceutical or biotech environment
3. Strong understanding of FDA, EU compliance regulations, and GAMP guidelines related to CSV
4. Experience with computerized system lifecycle validation deliverables
5. Experience with ERP systems, EQMS systems, PLC/SCADA, DCS, laboratory instrumentation, or process automation technologies
6. Familiarity with off-the-shelf, configurable, and custom-developed applications
7. Experience within pharmaceutical manufacturing environments preferred
8. Proficiency with Microsoft Office and quality systems software
9. Strong communication and cross-functional collaboration skills