Job Title: Senior Validation Engineer

Start Date: Immediate

Duration: 6 months plus Extensions

Work Location: Boston, MA (100% Onsite)

Job Overview

We are looking for an experienced Senior Validation Engineer - flexible working 100% Onsite. This role requires hands-on expertise in sterile and cleaning validation processes, excellent technical writing abilities, and the capacity to execute validation protocols independently.

Key Responsibilities

• Develop and implement sterile and cleaning validation protocols (IQ, OQ, PQ, CVP) in compliance with FDA, ISO 13485, and GMP standards.
• Perform risk assessments and conduct gap analyses to ensure adherence to validation requirements.
• Execute validation activities for autoclaves, cleanrooms, sterilization methods (EtO, gamma, steam), and CIP/SIP systems.
• Oversee cleaning validation processes, including residue testing, recovery studies, and establishing acceptance criteria.
• Author technical reports, validation master plans (VMPs), and comprehensive summary reports.
• Support FDA inspections and audits by providing expertise on validation activities.
• Identify opportunities for process optimization and address validation deviations effectively.

Required Qualifications

• Over 10 years of expertise in sterile and cleaning validation within the medical device, biotech, and pharmaceutical industries.
• Comprehensive knowledge of FDA regulations, ISO 13485, 21 CFR Part 820, EU MDR, and GMP compliance standards.
• Demonstrated proficiency in sterilization validation methods, including gamma, steam, and dry heat. Hands-on experience in cleaning validation, and strategies for bioburden reduction.
• Exceptional skill in authoring and reviewing validation documentation with a high level of technical accuracy.
• Proficient in using advanced validation software such as Kaye Validator.
• Experienced with QMS platforms, including MasterControl, for effective quality management.