Senior Process Validation Engineer

Chemence • Alpharetta, GA

75d • Onsite

About The Position

Chemence Medical Inc. seeks Sr. Process Validation Engineer in Alpharetta, GA to develop IQ/OQ/PQ protocols, coordinate and perform equipment qualifications, and ensure that automated process equipment that mass produce medical device consumables and other products, are designed, developed, or changed in compliance with specifications, requirements, safety, and Company and regulatory guidelines. The Sr. Process Validation Engineer will work closely with engineering, operations, and R&D teams to create and document procedures to validate products and processes.

Requirements

• Bachelor's degree in Mechanical Engineering or a related Life Science/Engineering discipline
• 3 years’ experience in Validation Engineering
• Experience developing Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) validation/qualification protocols for equipment within an FDA regulated pharma, medical device, or biotech industry

Responsibilities

• Develop IQ/OQ/PQ protocols
• Coordinate and perform equipment qualifications
• Ensure that automated process equipment that mass produce medical device consumables and other products, are designed, developed, or changed in compliance with specifications, requirements, safety, and Company and regulatory guidelines
• Work closely with engineering, operations, and R&D teams to create and document procedures to validate products and processes

What This Job Offers

• Job Type: Full-time
• Career Level: Senior