Computer Systems Validation Specialist

About Meitheal Pharmaceuticals

Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.meithealpharma.com.

Learn about our benefits at Meitheal Benefits

Job Summary

The Computer Systems Validation Specialist is responsible for Computer Software Validation and Assurance activities for Meitheal's GMP Computer Systems. This individual will be responsible for developing, updating and executing Software Lifecycle documents [Validation Plan, Qualification Protocols/Test Scripts, Risk Assessments, Validation Reports, Procedures, etc.] in accordance with their specified requirements and validated in accordance with FDA and other agency requirements.

Payrate is determined by considering a person's prior experience and competence.

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Author/Update Computer System Validation deliverables, including Validation Plans, User Requirements Specifications, Functional Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOP's and Change Control Documentation.
• Review of vendor provided validation documentation to determine suitability and alignment with company CSV SOPs and GAMP5.
• Support the release updates for all GMP related computer systems.
• Thorough knowledge of 21 CFR Part 11 (210, 211, 600, and 820), Data Integrity, GAMP5 requirements and FDA industry regulations.
• Collaborate with the Process Owners SMEs to determine, and document, appropriate user requirements
• Apply FDA's new CSA guidelines to leverage risk-based strategy for testing to reduce documentation burdens while maintaining product quality and safety.
• Participate in the development, implementation, and modification of Computer System Validation Standard Operating Procedures (SOP) based on current regulations and industry standards.
• Work with QA to resolve any discrepancies or issues encountered during the validation of a computer system.
• Support QA in periodic audits and inspections, ensuring that all validation documentation is audit ready.

Competencies

• Code of Federal Regulations and cGMP's relating to the field of Computer System Validation.
• Ability to write technical documents (like Validation Plan, URS, FRS, Traceability Matrix, IQ/OQ protocol and report, etc.).
• Strong verbal and written communication skills, good decision-making skills and time management skills is a must; ability to interface with all levels of the organization.
• Ability to establish clear priorities quickly, work effectively under pressure, handle multiple projects and meet deadlines
• Ability to quickly learn and understand multiple types of software programs and/or SaaS applications including but not limited to QMS, ERP, Serialization, eCTD, Software Testing Tools ValGenesis) etc.

Education and/or Experience Required

• Degree (Bachelor's or Masters) in Computer Science, Software Engineering or other relevant Science Field or equivalent relevant experience.
• 3+ years in a cGMP-related industry with Computer System Validation and 21 CFR Part 11 compliance.
• Previous experience in writing, reviewing and executing computer validation documentation (VP, IQ, OQ, PQ, VSR).
• Knowledge of cGMP, GDP, GAMP, 21CFR Part 11, Data Integrity and industry best practices.
• Ability to understand existing and new business processes and requirements, to ensure proper implementation and validation of systems.
• Experience with SaaS systems in GxP environment preferred.
• ASQ, ISTQB Certification relevant to Software Quality Assurance is a plus.

Computer Skills

Microsoft Office, Adobe Systems (Pro, Acrobat DC), TrackWise/TrackWise Digital, SAP, Docubridge, Software Testing Tools

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this Job, the employee is regularly required to sit. The employee is occasionally required to stand; walk and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Assimilate to changing environments.
• Ability to prioritize and multitask.
• Organized and detailed orientated.
• Have a sense of urgency to meet all required deadlines

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled.