Onsite CSV Engineer — Pharma Validation & Compliance Lead

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 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.