- Conduct validation activities, including requirements gathering, validation planning, design qualification, test plan and script creation, test script execution, discrepancy management, and preparation of system descriptions and validation summary reports.
- Perform system-based risk assessments to determine GxP applicability, assess associated risks, and define validation activities based on risk levels.
- Assist the Validation Team with all aspects of the computer system and computerized equipment lifecycle during projects and operational phases, including the development, review, and execution of validation documentation.
- Provide validation support during the operational phase by conducting change impact assessments, determining required testing levels, authoring and executing test scripts related to changes, and preparing change qualification reports.
- Support periodic reviews of computer systems and user access reviews for computerized equipment.
- Assist in the business administration of the electronic validation lifecycle management system (ValGenesis).
- Train end users on the ValGenesis system.
- Manage and update validation templates in ValGenesis.
- Bachelor's degree in a Science or Engineering discipline.
- Minimum of 5 years of relevant experience in computer system validation.
- Experience with computer systems supporting R&D functions such as Clinical, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs, and Quality Assurance is advantageous.
- Familiarity 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.
- Ability to objectively review and make judgments within the wider context of quality and compliance.
- Strong troubleshooting skills.
- Effective collaboration and teamwork with cross-functional teams.
- Capability to manage a high volume of simultaneous projects and validation activities.
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Validation Engineer - Waltham, United States - GQR
Description
Title: Validation Engineer (CSV)
Location: Waltham, MA
Status: 6-month contract
Hourly rate: $60
Please note that this role is not able to provide sponsorship or work on a C2C basis.
Position Overview:
The Computer System Validation Specialist will support the validation activities for computer systems and computerized equipment, ensuring compliance with policies and procedures. This role encompasses both local and global enterprise systems, as well as SaaS (Software as a Service) solutions, and reports to the Manager of Validation.
Key Responsibilities:
Qualifications:
Skills and Abilities:
This role is critical in maintaining the integrity and compliance of computer systems and ensuring they meet regulatory standards and internal policies.
