Senior Computer Systems Validation Engineer

CooperCompanies•Trumbull, CT

1d•Onsite

About The Position

CooperSurgical 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 CooperCompanies, they are driven by a unified purpose to enable patients to experience life's beautiful moments, guided by shared values of being dedicated, innovative, friendly, partners, and doing the right thing. They currently offer over 600 clinically relevant medical devices, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. The Senior Computer Systems Validation Engineer is responsible for the validation of global computer systems, monitoring changes with regulations, and assisting team members for CSI’s corporate CSV strategy to meet all applicable regulations. This role provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in regulated environments. This role is responsible for establishing and maintaining the corporate CSV framework, overseeing critical programs and complex enterprise systems, ensuring regulatory inspection readiness, and driving a risk‑based, inspection‑ready validation culture across the organization.

Requirements

Experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.
Knowledge of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management methodologies.
Familiarity with computer systems used in support of GxP operations, and Computer System Validation documentation including CSV plans, requirements, risk assessments, test protocols (scripts), data migration plans/reports, traceability matrices, and summary reports.
Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent system.
Knowledge of regulatory requirements including CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP, ISO 13485, and ISO 14971.
Ability to effectively engage and collaborate with cross-functional teams, including IT, Quality Assurance, Validation, and business project stakeholders.
Knowledge of business enterprise functions and processes.
Experienced in organizing meetings.
Strong analytical and problem-solving skills with ability to identify issues, evaluate options, and implement effective solutions.
Ability to adapt to a fast and dynamic environment and effectively engage with various 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 skills (ability to communicate effectively with all stakeholders).
Effective time management skills with proven adaptability to shifting priorities, resource changes, and scheduling adjustments.
Ability to work independently and within teams (collaborative environment); self-motivated, self-directed, and detail oriented.
Proficiency with Microsoft Office, Microsoft D365, and Adobe Acrobat.
Experience/knowledge of Agile PLM, MasterControl, IQVIA, or equivalent QMS system.
Experience/knowledge of Waterfall, Agile, or Hybrid software development.
7 +years of experience in assigned function's business process, engineering, and supporting systems for QA and Compliance departments.
5+ years of experience in Computer Systems Validation.
Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience.

Nice To Haves

Experience/knowledge of automated systems for following activities/functions is preferred: Enterprise Resource Planning (Oracle E Business Suite)
Experience/knowledge of automated systems for following activities/functions is preferred: Document management (SharePoint)
Experience/knowledge of automated systems for following activities/functions is preferred: Requirements and Testing (JIRA/Azure DevOps/HP ALM/HPQC)
Experience/knowledge of automated systems for following activities/functions is preferred: Change/Incident Management (ServiceNow)
Experience/knowledge of automated systems for following activities/functions is preferred: Project/Task Management (Smartsheet/Excel spreadsheets)

Responsibilities

Lead and guide Computer Systems Validation tasks and deliverables through enterprise and high‑risk programs throughout the systems life cycle.
Propose streamlined approaches for CSV strategy and governance to meet compliance and usage of CSA.
Ability to lead validation projects and/or validation tasks/phases of larger projects (including eQMS and Quality Systems).
Drive inspection readiness and continuous improvement in CSV team.
Train and mentor project team personnel (testers, business systems analysts) in computer systems lifecycle methodology.
Work closely with IT, manufacturing, quality control, quality assurance, infrastructure, and other teams to provide guidance on CSV.
Provide guidance with functional/end user requirements, compliance, and system specifications, and ensure proper documentation is maintained to drive operational excellence.
Provide test execution training and assist teams with discrepancy management.
Support process owners for quality management systems and associated policies, procedures, and work instructions.
Oversee requirements traceability matrices for completeness of appropriate documentation and testing for user specific requirements.
Review and identify critical issues.
Ensure compliance with internal and external computer system lifecycle policies and regulations.
Communicate effectively with users to identify needs and evaluate alternative business solutions with project/QA Operations/Quality Management/Regulatory/IT Compliance.
Ensure issues are identified, tracked, reported, and resolved in a timely manner.
Perform other duties as assigned.