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Validation Engineer

Waltham, MA 02451

Posted: 06/13/2024 Employment Type: Contract Job Category: Engineering Job Number: 607500 Is job remote?: No Country: United States

Job Description

The holder of this position is charged with supporting computer system/computerised equipment validation activities and ensuring compliance with policies and procedures. Position scope includes local and global enterprise systems as well as SaaS (Software as a Service) solutions. This role will report into the Manager of Validation.

• Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports.
• Perform system-based risk assessments in determining GxP applicability of the system, associated risk and resulting validation activities per risk.
• Support Validation Team on all aspects of the computer system/computerised equipment lifecycle during projects and operational phase, including but not limited to development, review and execution of validation documentation.
• Provide validation support during the operational phase by performing change impact assessments, determine the required level of testing, authoring and executing test scripts related to the change and change qualification report.
• Support periodic review of computer systems.
• Support periodic user access review of computer systems/computerised equipments.
• Support business administration of the electronic system (ValGenesis) used for validation lifecycle management.
• Support training of end users on the electronic system (ValGenesis) used for validation lifecycle management.
• Support management of Validation Templates in ValGenesis in terms of authoring/updating templates.

? Bachelor’s degree in a Science or Engineering discipline with 5 years relevant experience in computer system validation.

• Experience computer systems supporting R&D functions like 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 but not limited to 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.
? Ability to make judgements in the wider context of quality/compliance
? Ability to perform effective trouble shooting
? Ability to collaborate and work with cross-functional teams
? Ability to manage high volume of simultaneous projects/validation activities

Pay ranges between $55-65/hr based on experience 
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About Waltham, MA

Discover exciting job opportunities in the vibrant area surrounding Waltham, Massachusetts! Known for its rich history, picturesque scenery, and bustling economy, Waltham offers job seekers a unique blend of innovation and tradition. Home to renowned universities, cutting-edge technology companies, and a thriving cultural scene, this city has something for everyone. Explore job listings in this region and unlock the door to a career filled with growth, charm, and endless possibilities. From strolling along the Charles River to catching a game at Fenway Park, there's no shortage of enchanting experiences waiting for you in the Waltham area. Start your job search today and embark on a rewarding career journey in one of the most inviting locations in the Northeast.

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