Senior Process Validation Engineer

Job Description

Job Description

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.

QUALIFICATIONS:

• Good verbal/written communicator with good facilitation and listening skills and ability to write clear and concise technical reports.
• Flexible with ability to multi-task and work independently and in cross functional teams.
• Ability to resolve conflicts and facilitate solutions.
• ·Ability to advocate for internal and external customers.
• Understanding of GMP Quality System Regulation for medical devices 21CFR820, 21CFR Part 11 and Current Good Manufacturing Practices (CGMPs)
• Experienced with FDA medical device manufacturing and ISO 13485 is a plus.
• Ability to quickly learn new technologies and applications as necessary to understand validation requirements.
• Working knowledge of quality tools helpful, including statistical techniques, technical writing, metrology and calibration, inspection and testing, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), sampling principles and Acceptable Quality Level (AQL), process mapping, risk analysis, cause and effect diagrams and Pareto analysis.
• Excellent problem solving (Six Sigma), root cause analysis, and process improvement skills with automated manufacturing and process control equipment.
• Highly proficient in Windows MS Office (Excel, Word, Outlook, PowerPoint, Teams) applications.

EDUCATION/EXPERIENCE:

• Bachelor’s Degree in Science/Engineering or related Life Science
• 7+ years of FDA-regulated GMP experience (pharma, medical device or biotech)