Senior Engineer, Computer System Validation Specialist

Job not on LinkedIn

🔥 0 minutes ago

🇨🇦 Canada – Remote

💵 $81.4k - $131.4k / year

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Implement Innomar’s CSV strategy and lead validation efforts for GxP-impacting computerized systems • Ensure compliance with PIC/S Annex 11 and 21 CFR Part 11 requirements • Review and develop validation strategies and associated documentation • Prepare Validation Plans, Requirements Traceability Matrices, Risk Assessments, IQ/OQ/PQ protocols, test cases, Validation Summary Reports, change controls, and SOPs • Evaluate changes in validated computerized systems using a risk-based approach • Design, create, execute, and review risk-based functional, integration, challenge, regression, and other applicable test cases • Prepare test data for validation activities • Guide validation team members, operational business units, IT, and third-party vendors in developing validation deliverables • Obtain and review unit test documentation from IT development teams or vendors • Manage defects, deviations, and incidents during validation projects • Organize triage meetings and determine resolution plans with stakeholders • Maintain defect, deviation, and incident logs through project closure • Coordinate documentation review, approval, execution, and post-execution review activities • Maintain and archive CSV documentation • Train validation project team members on testing and validation policies, practices, and tools • Provide quality guidance and assessments for validated systems • Conduct QA audits of IT and validation processes • Review and provide input to CSV-related SOPs and policies • Keep current with relevant industry and regulatory guidelines • Comply with company policies, procedures, safety rules, and regulations • Report to the QA Testing & Validation Team Lead or Manager

🎯 Requirements

• Minimum of three (3) years of hands-on experience validating GxP computerized systems and working with software development methodologies • A college or university degree in computer science, information technology, information security, engineering, software programming, or a related discipline is required • Formal training in computer sciences, business administration, or similar vocations through a four-year Bachelor’s Degree program, technical vocational training, or equivalent combination of experience and education • Thorough knowledge of CSV processes and regulatory requirements, including ISPE GAMP 5, 21 CFR Part 11, Annex 11, PIC/S, ICH, and GxP guidelines • Effective oral and written communication • Understanding of quality assurance and quality systems principles • Experience auditing IT processes and validated computerized systems • Excellent teamwork and interpersonal skills • Leadership and relationship-building skills • Strong analytical, problem-solving, and conceptual skills • Excellent organizational skills and attention to detail • Ability to resolve system issues effectively and efficiently • Ability to prioritize workload and meet deadlines • Practical understanding of project management principles and methodologies • Experience in a matrixed environment and collaborating with external vendors is preferred • Experience creating and reviewing Standard Operating Procedures (SOP) is desirable • Experience using automated enterprise testing tools is an asset • Experience with Kneat PVP, qTest, JIRA, HP ALM, or equivalent platforms is an asset • Working knowledge of relevant technologies, testing tools, automation platforms, Microsoft Copilot, or other AI-enabled tools is an asset

🏖️ Benefits

• Medical, dental, and vision care • Backup dependent care • Adoption assistance • Infertility coverage • Family building support • Behavioral health solutions • Paid parental leave • Paid caregiver leave • Training programs • Professional development resources • Mentorship programs • Employee resource groups • Volunteer activities • Reasonable accommodations during the employment process