Validation Expert
4 days ago
Job Summary
">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.
">About the Role
">- 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
Requirements
">- 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
Salary and Benefits
">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.
">Work Environment
">This role will be based in our non-temperature-controlled warehouse and production floor, with occasional work in our temperature-controlled office.
">What We Offer
">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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