Computer System Validation (CSV) Specialist

The Computer System Validation (CSV) Specialist ensures all computerized systems in regulated industries meet stringent regulatory requirements for functionality, security, and data integrity. The role includes creating validation plans, conducting testing, documenting results, managing deviations, ensuring regulatory compliance, and providing ongoing system support. Based in Nashville, TN, this position is open to Canadian citizens eligible for a TN visa.

Visa Requirements:

• Canadian citizens may apply; TN visa required.

Key Responsibilities:

System Validation:

• Ensure all computerized systems perform consistently as intended throughout their lifecycle.
• Validate system functionality, security, and data integrity in compliance with regulatory standards such as FDA, GxP, and 21 CFR Part 11.

Validation Planning and Testing:

• Develop and execute validation plans, including risk assessments, test protocols, and acceptance criteria.
• Conduct and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Documentation and Compliance:

• Create and maintain detailed validation documentation, including protocols, test scripts, validation reports, and system lifecycle documents.
• Ensure all validation activities are traceable, auditable, and meet regulatory compliance requirements.

Deviation Management:

• Identify, document, and manage validation deviations.
• Develop and implement corrective and preventive actions (CAPAs) to resolve issues and improve processes.

Ongoing System Support:

• Provide continuous support for validated systems to ensure they remain compliant, secure, and operational.
• Periodically review and revalidate systems as necessary to address changes in regulatory requirements or system modifications.

Collaboration and Training:

• Work with cross-functional teams, including IT, quality assurance, and operations, to implement and maintain validated systems.
• Provide training and guidance to end-users on validated systems and their compliance requirements.

Qualifications:

Education:

• Bachelor’s degree in Computer Science, Life Sciences, Engineering, or a related discipline.

Experience:

• Experience in computer system validation within regulated industries such as pharmaceuticals, medical devices, or biotechnology.
• Familiarity with regulatory standards, including FDA, GxP, 21 CFR Part 11, and ISO.

Skills and Knowledge:

• Strong understanding of validation principles, system lifecycle management, and risk-based approaches.
• Proficiency in writing validation documentation, test protocols, and reports.
• Knowledge of data integrity principles and best practices.
• Strong problem-solving and organizational skills.

Skills Summary:

• Core Expertise: Computer system validation, risk-based validation, regulatory compliance.
• Industry Knowledge: FDA, GxP, 21 CFR Part 11, ISO standards.
• Soft Skills: Documentation, collaboration, training, problem-solving.
• Tools: Validation management tools, test execution software.

The pay range that the employer in good faith reasonably expects to pay for this position is $25.43/hour - $39.73/hour. Our benefits include medical, dental, vision and retirement benefits. Applications will be accepted on an ongoing basis. Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.

Salary : $25 - $40