What are the responsibilities and job description for the CSV Validation Specialist position at Invent Staffing?
Key Responsibilities:
- Perform Computer System Validation (CSV) activities for remediation projects, ensuring compliance with regulatory standards.
- Validate and support the implementation of Empower Software, PLC manufacturing lab equipment, and Rockwell systems.
- Ensure compliance with industry regulations, including 21 CFR Part 11 and GAMP 5 guidelines.
- Develop, execute, and document validation protocols (IQ/OQ/PQ) for software, hardware, and equipment in manufacturing and laboratory environments.
- Collaborate with cross-functional teams such as QA, IT, and manufacturing to align validation efforts with project timelines and quality standards.
- Troubleshoot and resolve CSV-related issues effectively.
- Provide expert guidance on CSV issues, especially in highly regulated environments.
Requirements:
- Minimum of 5 years of experience in Computer System Validation (CSV) within the pharmaceutical, biotech, or related industries.
- Hands-on experience with Empower Software, PLC manufacturing lab equipment, and Rockwell systems.
- In-depth knowledge of FDA and EU regulatory requirements, including 21 CFR Part 11 and GAMP 5.
- Proven ability to develop and execute validation protocols (IQ/OQ/PQ).
- Ability to work independently while remaining aligned with team objectives and supervision.
- Strong communication and problem-solving skills.
- Excellent documentation and technical writing abilities.
Qualifications:
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field (preferred).
- Certification or training in CSV or related validation methodologies (preferred).
- Experience with FDA-regulated environments is required.
