Computer Systems Validation Specialist at Perspective Therapeutics

Chicago, Illinois, United States -

Full Time

Start Date

Immediate

Expiry Date

07 May, 26

Salary

0.0

Posted On

06 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Computer Systems Validation, Quality Assurance, Validation Plans, Test Procedures, Regulatory Compliance, Data Analysis, Standard Operating Procedures, Collaboration, Communication, Automated Testing Tools, Risk-Based Validation, Analytical Skills, Problem-Solving Skills, Interpersonal Skills, Documentation, Quality Management

Industry

Pharmaceutical Manufacturing

Description

Objective 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. Essential Functions Validation Planning & Execution: 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. System Audits & Data Analysis: 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. Procedure Development: 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. Regulatory Compliance & Consultancy: 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. Collaboration & Communication: 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. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Education / Experience 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. 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. Knowledge / Skill / Ability 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. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. This role operates in a regulated pharmaceutical setting, requiring adherence to cGMP, GLP, and other relevant standards. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Occasional travel may be required for audits, system installations, or cross-site collaboration. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training. For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.

How To Apply:

Incase you would like to apply to this job directly from the source, please click here

Responsibilities

The Computer Systems Validation Specialist will develop and execute validation plans for IT systems to ensure compliance with regulations. They will also conduct audits, analyze data, and collaborate with cross-functional teams to communicate findings and recommendations.