What are the responsibilities and job description for the Senior Validation Engineer ( Only W2) position at Xoriant US Staffing?
IT Quality Assurance Associate/Senior Validation Engineer
Plainsboro NJ
Long Term Contract
Job Overview:
We are seeking an IT Quality Assurance Associate to ensure compliance with regulatory standards (e.g., FDA 21 CFR Part 11) for computerized system validation (CSV) in a GxP-regulated environment. The role involves leading validation processes, reviewing CSV documents, and providing risk-based guidance for new systems.
Key Responsibilities:
- Oversee validation of GxP systems (on-premises and cloud-based).
- Review and approve CSV lifecycle documents.
- Provide compliance guidance and evaluate new systems for GxP impact.
- Manage incidents and changes for GxP impact, ensuring validation requirements are met.
Qualifications:
- Bachelor’s degree in computer science, IT, Life Sciences, or related field.
- Minimum 4 years of experience in CSV within the pharmaceutical or regulated industries.
- Strong knowledge of regulatory guidelines (e.g., FDA 21 CFR Part 11).
- Experience in project management and cross-functional team collaboration.
- Excellent communication and problem-solving skills.
Salary : $50 - $55
