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Validation Engineer/Specialist

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Education:Bachelor of Science in Engineering (fields such as Computer Science, Chemical, Mechanical, Electrical, etc.)Minimum Skills:3 to 5 years of practical validation experience, including writing and executing validation protocols. Able to work autonomously with minimal supervision while effectively collaborating with project teams to meet deadlines. Exceptional technical writing and communication abilities. Proficient in Microsoft Office applications, including Word, Excel, and Project. Strong interpersonal and problem-solving skills, with a keen eye for detail and commitment to excellent documentation practices.

About the job

  • Utilize a Risk-Based Approach to enhance Commissioning and Qualification practices in medical device manufacturing, particularly for Class II products.
  • Develop and coordinate Commissioning and Qualification activities effectively throughout the manufacturing process.
  • Conduct comprehensive Risk Management practices, including assessments, Functional Risk Documents, and pFMEA.
  • Oversee equipment qualification and process validation to ensure compliance and efficiency.
  • Implement Computerized System Validation for PLC, HMI, and related systems.
  • Ensure adherence to 21 CFR Part 11 requirements by integrating them into a streamlined testing strategy.
  • Support deviation investigations and resolve issues encountered during execution activities in the field.

About Validation Engineering Group, Inc.

Validation Engineering Group, Inc. is a premier service provider dedicated to delivering innovative solutions across the Pharmaceutical, Biotechnology, Chemical, and Medical Devices sectors. Our expertise spans Laboratory Compliance, Engineering, Project Management, and Validation services, ensuring that our clients meet the highest industry standards.

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