Overview As a CSV Contractor, you will lead validation activities for GxP electronic systems, partnering with cross-functional stakeholders to ensure compliant documentation across the validation lifecycle. You'll support MES validation efforts within the regulatory framework, contributing to high-quality CSV deliverables. This role blends technical compliance with collaboration across Business Owners, Technical Owners, and Quality. You will help shape validated systems that enable reliable manufacturing operations and product development.
Responsibilities- Author/review/approve CSV documentation
- Assist during test execution and document failures to ensure alignment with procedures
- Help Business Owners/Technical Owners develop requirements and specifications for computerized systems in GxP operations
- Other related duties as assigned
Key requirements- 4+ years of direct CSV experience
- Strong knowledge of GAMP, risk-based validation approaches, cGMP, GXP, and 21 CFR Part 11
- Experience with MES validation (e.g., SynCad/Emerson Syncade) and related ERP and EBR systems (e.g., SAP, Oracle, InfoBatch)
- Ability to develop CSV documentation (Validation Plans, Requirements, Specifications, IQ/OQ/PQ, Summary Reports, Trace Matrices, SOPs)
- Familiarity with IT service management platforms (e.g., ServiceNow) and quality systems (e.g., Veeva)
- Strong communication, problem-solving, and independent work capability
- Understanding of electronic records and signatures and good documentation practices
- Strong interpersonal skills
- Teamwork and client focus
- Excellent verbal and written communication
- CSV for GxP systems
- GAMP and risk-based validation
- IQ/OQ/PQ documentation
