Computer Systems Validation Specialist

Perspective Therapeutics•Chicago, IL

12h

About The Position

The Computer Systems Validation (CSV) Specialist will play a critical role within the Quality organization, ensuring compliance of information technology systems with applicable regulations and standards. The ideal candidate will have a strong background in computer systems validation and quality assurance, with a focus on developing, executing, and maintaining validation plans, procedures, and documentation.

Requirements

Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field.
A minimum of 5 years of experience in computer systems validation, quality assurance, or related roles within the pharmaceutical, biotech, or healthcare industries.
Strong knowledge of regulatory requirements, including GxP, FDA 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.
Proficiency in automated testing tools and validation methodologies.
Experience in drafting and maintaining validation documentation and test protocols.
Familiarity with risk-based validation approaches and quality risk management principles.
Exceptional analytical, organizational, and problem-solving skills.
Strong communication skills to effectively collaborate with cross-functional teams and provide validation insights.
Ability to manage multiple projects and meet deadlines in a fast-paced environment.
Ability to work in a team environment with minimum supervision required.
Strong interpersonal skills and an understanding of group dynamics.

Nice To Haves

Experience with enterprise systems such as LIMS, ERP, or MES in a validated environment preferred.
Certification in quality assurance, such as ASQ Certified Quality Auditor (CQA) or similar preferred.
Knowledge of data integrity principles and compliance frameworks highly desired.

Responsibilities

Develop and design validation plans for IT systems, ensuring compliance with applicable regulations (e.g., 21 CFR Part 11, GAMP 5, EU Annex 11).
Perform test coverage analysis, execute test procedures, and document results.
Write, review, and approve validation documentation, including protocols (IQ, OQ, PQ) and reports.
Conduct internal and external audits of computer systems to assess compliance with quality standards.
Analyze data, prepare test results, and provide comprehensive reports to cross-functional teams.
Develop, review, and update standard operating procedures (SOPs), policies, and guidelines for computer systems validation.
Ensure documentation aligns with global regulations and quality management practices.
Provide advice and consultancy on international quality assurance regulations and guidelines for computer systems and data management.
Stay current with regulatory updates and industry trends, incorporating them into validation activities.
Collaborate with IT, Quality Assurance, and other departments to ensure alignment of validation activities with organizational goals.
Communicate findings, test results, and recommendations effectively to stakeholders.