Senior Validation Engineer

1 month ago


Columbus, United States The Fountain Group Full time
Job DescriptionJob Description

Job Description:

  • Seeking Validation Support for Project Execution -- Drafting, Documentation as part of FDA compliance for new process equipment and packaging equipment validation. Standards: 21 CFR Part 11 compliance is the majority.
  • Documentation including URS (User Requirements Specifications) / FMEA / SIA / Design Qualifications / Functional requirement qualifications, IQ/OQ/PQ documentation – everything in V model validation approach. Would be partnered up with site engineers for detailed engineers.
  • Draft those documents >> get them approved >> support the execution and sign off of those documentation for equipment validation. We use M-Files, MS Project – all a plus.
  • Degree with min. 5+ years’ experience sought – experience in an FDA regulated industry (Med Device/ Pharma or similar) required.
Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.

Browse our website below for additional information on our company.

The Fountain Group

4505 Woodland Corporate Blvd, Tampa, FL 33614
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”Company DescriptionThe Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort.\r
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Browse our website below for additional information on our company.\r
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The Fountain Group\r
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4505 Woodland Corporate Blvd, Tampa, FL 33614\r
“We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people.”

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