Sr. Computer Systems Validation Engineer

Job Description

Scope:

The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations.

Job Summary:

The Senior Computer Systems Validation Engineer 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.

Responsibilities

Essential Functions & Accountabilities:

• 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, projgram management, 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.
  
  Travel: This position may require 5-10% domestic and/or foreign travel.

Qualifications

Knowledge, Skills, and Abilities:

• 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 in support of GxP operations, and Computer System Validation documentation including, the authoring of plans, requirements, risk assessments, test protocols, test reports, traceability matrices, and summary reports.
• Experience and knowledge of various QMSs, Agile PLM, MasterControl, Veeva, TrackWise, or equivalent systems.
• 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 such as: IT, Regulatory, Quality Assurance, PMO, R&D, project stakeholders, business owners, system owners, etc.
• Knowledge of business enterprise functions and processes. Experienced in organizing meetings.
• Strong analytical and problem-solving skills with the 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.
• Experience/knowledge of automated systems for following activities/functions is preferred: QMSs, ERPs, LIMS, Change/Incident Management (ServiceNow), Requirements and Testing (DevOps, JIRA, etc.), and Project/Task Management.

Work Environment:

• Prolonged periods of sitting, especially in front of a computer.
• Potential exposure to different manufacturing environments and following various safety protocols.

Experience:

• 7 years of experience in the assigned function's business process, engineering, and supporting systems for QA and Compliance departments.
• 5 years of experience in Computer Systems Validation

Education:

• Bachelor of Science Degree, Computer Engineering, or relevant science field required, or equivalent combination of education and experience.