Pharma CSV Validation Project Lead

Stallergenes Greer Ltd; North Carolina; On-site; USD 90,000 - 120,000; Full time

Job summary

Stallergenes Greer Ltd in Lenoir, NC seeks a Systems Validation Specialist to lead pharmaceutical CSV validation projects, define technical needs, and deliver validation deliverables across master plans, protocols, and summary reports.

The role requires 3+ years in a highly regulated pharma/medical devices environment, strong knowledge of FDA/GAMP guidelines, and experience with ERP/EQMS systems. On-site collaboration with Validation, Engineering, and QA teams is essential.

Qualifications

• Bachelor’s degree required in CS/Engineering or related field.

Responsibilities

• Execute pharmaceutical CSV validation project assignments including implementation of new systems, remediation of legacy, and re-validation of existing computerized systems.
• Coordinate and interface with Validation Manager, engineering and quality assurance groups to ensure successful project execution.
• Lead cross-functional project teams in the development of validation deliverables.
• Review and approve validation project documentation.
• Develop validation deliverables including master plans, protocols and summary reports, as required.

Skills

Project management

Regulatory compliance

GxP knowledge

ERP / EQMS familiarity

Education

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

Tools

ERP systems

EQMS

Calibration software

Building management software

Quality systems software

Job description

Stallergenes Greer Ltd in Lenoir, NC seeks a Systems Validation Specialist to lead pharmaceutical CSV validation projects, define technical needs, and deliver validation deliverables across master plans, protocols, and summary reports.

The role requires 3+ years in a highly regulated pharma/medical devices environment, strong knowledge of FDA/GAMP guidelines, and experience with ERP/EQMS systems. On-site collaboration with Validation, Engineering, and QA teams is essential.