Cleaning Validation Engineer

QvalFocus Inc.; Massachusetts; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device manufacturer is seeking an experienced Cleaning Validation Engineer in the United States, Massachusetts. This role involves executing cleaning validation activities, ensuring compliance with regulations, and collaborating across teams. Ideal candidates have 5+ years in regulated manufacturing, a strong background in Good Manufacturing Practice, and excellent documentation skills. Join a dedicated team to enhance product quality and compliance in medical device manufacturing.

Qualifications

• 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.

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.

Skills

Cleaning validation experience

Documentation skills

Communication skills

Education

Bachelor’s degree in Engineering or related field

Job description

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

Requirements

• 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