Description
We are seeking a highly skilled Computer System Validation (CSV) Specialist to join our team. The ideal candidate will have strong experience in validating computerized systems within regulated environments, ensuring compliance with applicable regulations such as FDA 21 CFR Part 11 and GxP guidelines. This role will focus on the validation lifecycle, system configuration, and ensuring data integrity across critical systems.
Key Responsibilities:
- Perform Computer System Validation (CSV) activities in compliance with FDA, GxP, and other applicable regulatory requirements.
- Author, review, and execute validation lifecycle documentation including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ensure systems are compliant with 21 CFR Part 11 and align with GAMP 5 guidance.
- Support and troubleshoot Category 4 (Configurable) systems, ensuring proper configuration and validation.
- Ensure data integrity principles are consistently applied across all systems and validation processes.
- Collaborate with cross-functional teams including Quality Assurance, IT, and system owners to maintain validated state of systems.
- Provide support for audit and inspection readiness by maintaining accurate and complete validation documentation.
- Preferred: Experience working with cytometry platforms such as FacsCantos or MacsQuants.
- Maintain high-quality documentation and demonstrate strong communication skills for both technical and non-technical stakeholders.
Requirements
- Bachelor’s degree in Life Sciences, Computer Science, Engineering, or a related field.
- 3+ years of experience in computer system validation within regulated environments.
- In-depth knowledge of CSV best practices, validation lifecycle (IQ/OQ/PQ), and regulatory standards.
- Familiarity with 21 CFR Part 11, GAMP 5, and ALCOA+ data integrity principles.
- Hands-on experience with troubleshooting and configuration of Category 4 systems.
- Excellent technical writing and interpersonal communication skills.
- Experience with FacsCantos or MacsQuants systems is a plus.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
