Job Details
The Computer System Validation Engineer is responsible for supporting validation activities of computer systems and computerized equipment to ensure compliance with CLIENT policies and procedures. This role encompasses local and global enterprise systems as well as SaaS (Software as a Service) solutions
Key Areas of Job Accountability:
- Support validation activities including requirements gathering, validation planning, design qualification, test plan authoring, test script execution, discrepancy management, and authoring system description and validation summary reports.
- Conduct system-based risk assessments to determine GxP applicability, associated risks, and necessary validation activities.
- Assist the Validation Team with the computer system/equipment lifecycle during projects and operational phases, including developing, reviewing, and executing validation documentation.
- Provide validation support during the operational phase by performing change impact assessments, determining required testing levels, authoring, and executing test scripts related to changes, and compiling change qualification reports.
- Support periodic review and user access review of computer systems/computerized equipment.
- Assist in business administration of the electronic system (ValGenesis) used for validation lifecycle management.
- Train end users on the electronic system (ValGenesis) for validation lifecycle management.
- Manage validation templates in ValGenesis, including authoring and updating templates.
Qualifications:
- Academic/Technical Qualifications:
- Bachelor s degree in a Science or Engineering discipline.
- Minimum of 5 years relevant experience in computer system validation.
- Specialist/Technical Qualifications/Knowledge:
- Experience with computer systems supporting R&D functions such as Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs, and Quality Assurance is a plus.
- Experience with ValGenesis is a plus.
- Practical experience with quality risk management and risk-based validation approaches.
- Knowledge of cGMP regulations and guidelines including U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9, and Q10.
- Understanding of industry standards and best practices for computer system validation such as GAMP 5 and ASTM E2500.
Abilities and Judgement:
- Ability to objectively review and make judgements in the context of quality/compliance.
- Effective troubleshooting skills.
- Ability to collaborate and work with cross-functional teams.
- Capability to manage a high volume of simultaneous projects/validation activities.