What are the responsibilities and job description for the CSV Engineer position at Highbrow Technology Inc?
Job Title: Consultant – CSV Project Support
Location: Philadelphia, PA (On-Site)
Contract Duration: 1 Year
Required Skills and Experience:
- Previous experience supporting a CSV project in a commercial pharmaceutical environment.
- Experience with MasterControl or a similar eQMS (electronic Quality Management System).
- Experience working with the ISPE GAMP 5 framework for software validation.
- Prior experience onboarding or qualifying enterprise-based systems (e.g., SAPB1 environment).
- Proven ability to draft the following documents:
- URS (User Requirement Specifications)
- Configuration Specification Documents
- CSV IOPQ (Computerized System Validation Installation/Operational/Performance Qualification)
- Traceability Matrix
Key Skills:
- Strong understanding of pharmaceutical industry regulations and compliance standards.
- Ability to manage and execute validation activities throughout the project lifecycle.
- Excellent communication skills for collaboration with cross-functional teams and vendors.
