Junior Computer Systems Validation Engineer

Junior Computer Systems Validation Engineer

Cooper Surgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of Cooper Companies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at

This role involves maintaining computer system inventory listings, reviewing release notes, performing periodic reviews of validated systems, developing and executing validation protocols (IQ/OQ/PQ), supporting risk assessments for system changes, collaborating with cross‑functional teams, maintaining validation documentation, routing documents, maintaining validation templates, working on project teams during SDLC phases, performing periodic reviews, providing test execution training, ensuring issues are identified and resolved, and performing other duties as assigned.

• Maintains computer system inventory listing of all computer systems inventory. Review release notes and perform periodic reviews of validated systems.
• Assist in developing and executing validation protocols (IQ/OQ/PQ) for computer systems and related software.
• Support Risk Assessments for system changes.
• Collaborate with cross‑functional teams (Quality Assurance, IT, and Manufacturing) to troubleshoot and resolve validation issues.
• Maintain validation documentation in accordance with company SOPs and regulatory guidelines. Validation documentation includes validation plans, user and system requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.
• Routes documents for review and approval.
• Maintains validation templates.
• Ability to work on project teams for Software Development Life Cycle phases.
• Performs periodic reviews and supports remediation activities on validated systems.
• Provides test execution training and assists teams with deviation management.
• Ensures validation issues are identified, tracked, reported on, and resolved in a timely manner.
• Perform other duties as assigned.

This position may require 5–10% domestic and/or foreign travel.

• Experience in Computer Systems Validation, Software Quality Assurance of Quality Management Systems.
• Familiar with Systems Development Life Cycle Management (SDLC) and Change Management methodologies.
• Familiar with computer systems used in support of GxP operations.
• Knowledge of regulatory requirements including FDA 21 CFR Parts 11, 58, 211, 820, and 1271; SOX, GAMP, ISO 13485, and ISO 14971 with a basic understanding of GxP processes, risk-based approaches, and validation principles.
• Ability to effectively engage and collaborate with cross‑functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.
• Knowledge of the business enterprise functions and processes.
• Strong analytical and problem‑solving skills with the ability to identify issues, evaluate options, and implement effective solutions.
• Ability to effectively engage functional and technical teams.
• Skilled in developing, following, and maintaining procedures and supporting documentation to ensure compliance and consistency.
• Strong written, verbal, and interpersonal communication abilities.
• Effective time management with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.
• Demonstrates the ability to work independently and within teams; self‑motivated, self‑directed, and detail oriented. Experience working in a team‑oriented, collaborative environment.
• Ability to communicate effectively…