Validation Expert

4 days ago


Alpharetta, Georgia, United States Chemence Full time

Job Summary

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We are seeking a highly skilled Validation Expert to join our team at Chemence. As a key member of our quality assurance department, you will play a crucial role in ensuring the development and production of our medical devices meet the highest regulatory standards.

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About the Role

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  • Develop and implement validation protocols for new processes, equipment, and products
  • Lead cross-functional teams to execute validation activities and ensure compliance with cGMP, GLP, FDA, and international regulations
  • Mentor and train colleagues on validation methodologies, complex processes, and automated equipment
  • Collaborate with engineering, operations, supply chain, quality, and R&D teams to create and document validation, qualification, and periodic requalification of products and processes
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Requirements

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  • Bachelor's degree in Science/Engineering or a related Life Science field
  • 7+ years of FDA-regulated GMP experience, ideally in medical device manufacturing
  • Strong problem-solving skills, including root cause analysis and process improvement with automated manufacturing and process control equipment
  • Proficient in Windows MS Office applications (Excel, Word, Outlook, PowerPoint, Teams)
  • Preferred: Six Sigma Black Belt, Certified Quality Engineer, or similar certification
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Salary and Benefits

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The estimated salary for this position is $90,000 - $110,000 per year, depending on experience. We offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.

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Work Environment

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This role will be based in our non-temperature-controlled warehouse and production floor, with occasional work in our temperature-controlled office.

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What We Offer

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At Chemence, we value our employees' contributions and offer opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality and regulatory compliance, we encourage you to apply for this exciting opportunity.



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