Cleaning Validation Engineer
Job in
Newton, Middlesex County, Massachusetts, 02165, USA
Listed on 2026-02-21
Listing for:
QvalFocus Inc.
Full Time
position Listed on 2026-02-21
Job specializations:
-
Engineering
Medical Device Industry, Quality Engineering, Validation Engineer, Biomedical Engineer
Job Description & How to Apply Below
We are seeking an experienced Cleaning Validation Engineer with 5+ years in regulated manufacturing to lead and execute cleaning validation activities for medical device manufacturing equipment and facilities, ensuring compliance with regulatory and quality requirements.
Responsibilities- Execute cleaning validation protocols, reports, and SOPs
- Develop validation strategies aligned with FDA medical device regulations and ISO standards
- Perform MACO calculations, swab/rinse sampling, and risk assessments
- Support deviations, investigations, CAPA, and audits
- Collaborate with Quality, Manufacturing, and Engineering teams
- Bachelor’s degree in Engineering or related field
- 5+ years of Cleaning Validation experience in medical device or regulated manufacturing
- Strong knowledge of Good Manufacturing Practice / Quality System Regulations
- Strong documentation and communication skills
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