Senior Computer Systems Validation Engineer

This is a fully remote position, open to applicants in Connecticut.

📋 Description

• Oversee and direct Computer Systems Validation (CSV) activities and deliverables across enterprise-level and high-risk programs throughout the entire systems life cycle.

• Suggest efficient strategies for CSV governance and compliance to align with CSA usage.

• Manage validation initiatives and specific phases of larger projects, including eQMS and Quality Systems.

• Promote inspection readiness and ongoing enhancements within the CSV team.

• Educate and guide project team members, including testers and business systems analysts, on computer systems lifecycle methodologies.

• Partner with IT, manufacturing, quality control, quality assurance, infrastructure, program management, and other departments to deliver CSV expertise.

• Provide direction on functional and end-user requirements, compliance, and system specifications, ensuring proper documentation is upheld.

• Offer training on test execution and support teams in managing discrepancies.

• Assist process owners with quality management systems and the related policies, procedures, and work instructions.

• Supervise requirements traceability matrices and evaluate documentation, testing, and critical issues.

• Ensure adherence to both internal and external computer system lifecycle regulations and policies.

• Engage with users to determine needs and assess alternative business solutions in collaboration with project, QA Operations, Quality Management, Regulatory, and IT Compliance stakeholders.

• Ensure that issues are promptly identified, tracked, reported, and resolved.

• Carry out additional responsibilities as assigned.

⛳️ Requirements

• Proven experience in Computer Systems Validation, Software Quality Assurance, and Quality Management Systems.

• Understanding of Systems Delivery/Development Lifecycle Management (SDLC) and Change Management practices.

• Familiarity with computerized systems that support GxP operations.

• Demonstrated experience in writing CSV plans, requirements, risk assessments, test protocols, test reports, traceability matrices, and summary reports.

• Proficient with QMSs, Agile PLM, MasterControl, Veeva, TrackWise, IQVIA, or similar systems.

• Knowledge of CSV, CSA, FDA 21 CFR Parts 11, 58, 211, 820, and 1271; GAMP; ISO 13485; and ISO 14971.

• Ability to work collaboratively with IT, Regulatory, Quality Assurance, PMO, R&D, project stakeholders, business leaders, and system owners.

• Understanding of enterprise business functions and processes.

• Strong analytical and problem-solving abilities.

• Capacity to thrive in a fast-paced and dynamic environment.

• Competence in developing, adhering to, and maintaining procedures and relevant documentation.

• Excellent written, verbal, and interpersonal communication skills.

• Effective time management skills and ability to adapt to shifting priorities, resource changes, and scheduling modifications.

• Capability to work independently as well as collaboratively in teams; self-motivated, self-directed, and detail-oriented.

• Proficient in Microsoft Office, Microsoft D365, and Adobe Acrobat.

• Experience in Waterfall, Agile, or Hybrid software development methodologies.

• Familiarity with automated QMS, ERP, LIMS, ServiceNow, DevOps, JIRA, and project/task management systems is preferred.

• 7+ years of experience in the relevant business process, engineering, and systems support for QA and Compliance departments.

• 5+ years of experience specifically in Computer Systems Validation.

• A Bachelor of Science degree in Computer Engineering or a related science field is required, or an equivalent combination of education and experience.

• Ability to work in settings that require extended periods of sitting, particularly in front of a computer.

• Ability to adhere to safety protocols in various manufacturing environments.

🏝️ Benefits

• 5–10% domestic and/or international travel may be necessary.