On-Site Pharma CSV Engineer | Validation & Compliance

Stallergenes Greer U.S.; Lenoir (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

Stallergenes Greer U.S. in Lenoir, NC is seeking a qualified professional to lead software validation projects within a highly regulated pharmaceutical environment.

Responsibilities include executing CSV assignments, developing master plans, protocols and summary reports, and coordinating with Validation, Engineering and QA to ensure compliant project delivery; engage end users for URS/FRS, and support continuous improvement of validation practices.

Qualifications

• This position requires a Bachelor’s degree in CS/Engineering or related field.
• Minimum 3 years in a highly regulated pharma/biotech/medical devices environment.
• At least 1 year in project management with CSV/validation deliverables.

Responsibilities

• Execute pharmaceutical CSV validation project assignments including new system implementations, legacy remediation, and re-validation.
• Develop technical needs and provide recommendations for validation.
• Lead multiple CSV projects using Project Management methodologies.
• Coordinate with Validation Manager, Engineering and QA to ensure successful delivery.
• Develop validation deliverables: master plans, protocols, summary reports.
• Engage end users for URS/FRS generation and develop test scripts.

Skills

CSV Validation

Project Management

Regulatory Compliance

GAMP Knowledge

Pharma/Med Devices

ERP Systems

PLC/SCADA/DCS

Documentation

Education

Bachelor's Degree in CS/Engineering

Tools

EQMS

Calibration Software

Quality Systems Software

ERP Systems

MS Office

Job description

Stallergenes Greer U.S. in Lenoir, NC is seeking a qualified professional to lead software validation projects within a highly regulated pharmaceutical environment.

Responsibilities include executing CSV assignments, developing master plans, protocols and summary reports, and coordinating with Validation, Engineering and QA to ensure compliant project delivery; engage end users for URS/FRS, and support continuous improvement of validation practices.