Senior Process Validation Engineer

LocationAlpharetta, Georgia, United States

TypeOnsite

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.

Life at Chemence

Chemence is a leading European manufacturer of high performance adhesives and sealants comprising instant adhesives (superglues), engineering anaerobics, threadlockers, retainers, gasket makers, gas pipe sealants, window and building plastics adhesives, non-staining activators and UV curing products. We supply globally to the retail, automotive, transportation, gas distribution, construction, medical and electronics. We also specialise in the production of flexographic plates, ink-jet film production systems. Chemence is the owner of several established brand names:- Mitre Mate: The original 2 part mitre bonding kit Kwik-Fix: A range of Value retail packaged adhesives designed for smaller retail outlets Setfast: A large and varied range of eye catching retail packaged consumer products Plastic Mate: high quality adhesives aimed at the professional user. The newest addition to our brands... Krylex: A range of high quality, high performance adhesives and sealants designed for industry Visit the dedicated website at http://www.krylex.com Industrial Adhesives & Sealants, Instant Adhesives (Cyanoacrylate/Superglue), Primers & Activators, UV Curing Resins, Anaerobic Gasket Makers & Pipe Sealants, Anaerobic Retainers & Threadlockers, Nail Glue & Resin, UV Soak-Off Nail Polish, UV Curing Nail Gel

Thrive Here & What We Value

Provides equal employment opportunities to all employees and applicants for employment

Prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws

Emphasis on maintaining a clean work environment

Positive attitude towards work environment encouraged

Reasonable accommodations made for individuals with disabilities

Nontemperature-controlled warehouse and production floor environment

Supports diversity and inclusion in the workplace

Senior Process Validation Engineer

Summary:

Key Duties and Responsibilities:

Qualifications, Education and/or Experience Required:

Life at Chemence

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