Senior Engineer, Computer System Validation Specialist

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

📋 Description

• Execute Innomar’s Computer System Validation (CSV) strategy and spearhead validation initiatives for GxP-impacting computerized systems.

• Ensure adherence to PIC/S Annex 11 and 21 CFR Part 11 standards.

• Assess and formulate validation strategies alongside pertinent documentation.

• Develop Validation Plans, Requirements Traceability Matrices, Risk Assessments, IQ/OQ/PQ protocols, test cases, Validation Summary Reports, change controls, and Standard Operating Procedures (SOPs).

• Analyze modifications in validated computerized systems utilizing a risk-based methodology.

• Design, implement, execute, and evaluate risk-based functional, integration, challenge, regression, and other relevant test cases.

• Prepare test data required for validation processes.

• Provide guidance to validation team members, operational business units, IT, and third-party vendors in crafting validation deliverables.

• Collect and review unit test documentation from IT development teams or vendors.

• Oversee defects, deviations, and incidents during validation efforts.

• Facilitate triage meetings and establish resolution plans with stakeholders.

• Maintain logs for defects, deviations, and incidents throughout the duration of the project.

• Coordinate documentation review, approval, execution, and follow-up review activities.

• Preserve and archive CSV documentation.

• Educate validation project team members on testing and validation policies, practices, and tools.

• Offer quality guidance and assessments for validated systems.

• Conduct Quality Assurance (QA) audits of IT and validation procedures.

• Review and contribute to CSV-related SOPs and policies.

• Stay updated with relevant industry and regulatory standards.

• Follow company policies, procedures, safety regulations, and guidelines.

• Report to the QA Testing & Validation Team Lead or Manager.

⛳️ Requirements

• A minimum of three (3) years of practical experience in validating GxP computerized systems and familiarity with software development methodologies.

• A degree from a college or university in computer science, information technology, information security, engineering, software programming, or a related field is essential.

• Formal education in computer sciences, business administration, or similar fields through a four-year Bachelor’s Degree program, technical vocational training, or a comparable mix of experience and education.

• In-depth understanding of CSV processes and regulatory standards, including ISPE GAMP 5, 21 CFR Part 11, Annex 11, PIC/S, ICH, and GxP guidelines.

• Strong verbal and written communication skills.

• Comprehension of quality assurance and quality systems principles.

• Experience in auditing IT processes and validated computerized systems.

• Exceptional teamwork and interpersonal abilities.

• Skills in leadership and building professional relationships.

• Strong analytical, problem-solving, and conceptual capabilities.

• Excellent organizational skills and meticulous attention to detail.

• Ability to effectively and efficiently resolve system issues.

• Capacity to prioritize tasks and meet deadlines.

• Practical knowledge of project management principles and methodologies.

• Preferred experience in a matrixed environment and collaboration with external vendors.

• Desirable experience in creating and reviewing Standard Operating Procedures (SOPs).

• Familiarity with automated enterprise testing tools is advantageous.

• Experience with Kneat PVP, qTest, JIRA, HP ALM, or comparable platforms is beneficial.

• Working knowledge of relevant technologies, testing tools, automation platforms, Microsoft Copilot, or other AI-enabled tools is a plus.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Backup dependent care services.

• Assistance for adoption.

• Infertility coverage.

• Support for family building.

• Solutions for behavioral health.

• Paid parental leave.

• Paid caregiver leave.

• Training programs.

• Resources for professional development.

• Mentorship initiatives.

• Employee resource groups.

• Opportunities for volunteer activities.

• Reasonable accommodations throughout the employment process.