Senior Process Validation Engineer

Summary:

Key Duties and Responsibilities:

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.

Qualifications, Education and/or Experience Required:

• Must have a Bachelor's degree in Mechanical Engineering or a related Life Science/Engineering discipline.
• Must have 3 years’ experience in Validation Engineering, including 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.