Job Title: Senior CSV Specialist
Experience Required: 15+ Years
Location: 100% Onsite in Windsor, NJ

We are seeking a highly experienced Senior CSV Specialist to join our team in Windsor, NJ. This is an onsite, long-term opportunity for a seasoned professional with extensive expertise in Computer System Validation (CSV) and a proven track record of leading complex remediation projects. The ideal candidate will bring deep technical knowledge, leadership skills, and the ability to mentor junior team members while ensuring compliance with regulatory requirements and industry best practices.

• Lead and manage complex Computer System Validation (CSV) remediation projects, ensuring adherence to regulatory guidelines and industry standards.

• Validate Empower Software, PLC manufacturing lab equipment, and Rockwell systems with precision and thorough documentation.

• Conduct and oversee validation lifecycle processes, including:

  • Risk assessments

  • Gap analyses

  • Protocol development

  • Execution and reporting

• Provide mentorship and guidance to junior team members, fostering skill development and knowledge sharing.

• Ensure compliance with regulatory requirements, such as FDA, GAMP 5, and other relevant guidelines.

• Stay updated on industry best practices and emerging trends to drive continuous improvement in validation processes.

• Experience: 15+ years of proven expertise in Computer System Validation (CSV), with a strong focus on remediation projects.

• Technical Expertise:

  • Hands-on experience with Empower Software, PLC manufacturing lab equipment, and Rockwell systems.

  • Strong understanding of validation lifecycle processes, including risk assessments, gap analyses, and protocol execution.

• Regulatory Knowledge: In-depth understanding of FDA regulations, GAMP 5 guidelines, and industry best practices.

• Leadership Skills: Proven ability to lead validation projects and mentor junior team members effectively.

• Communication: Excellent written and verbal communication skills to prepare clear documentation and interact with cross-functional teams.

• Experience in pharmaceutical or biotechnology industries.

• Familiarity with data integrity principles and 21 CFR Part 11 compliance.

• Certification in CSV or related disciplines is a plus.