Senior Validation Engineer at LS Solutions

Title or Role: Validation Engineer, Sterile & Cleaning Validation

Location: Bedford, MA

Length of Contract: 6+ months

Job Description:

Position Overview

We are seeking an experienced Sterile & Cleaning Validation Engineer to support validation activities within a medical device manufacturing environment. The ideal candidate will have hands-on experience with sterile and cleaning validation processes, strong technical writing skills, and the ability to execute validation protocols independently. This role involves performing revalidation tasks for equipment and working closely with cross-functional teams.

Key Responsibilities:

• Develop and execute sterile and cleaning validation protocols (IQ, OQ, PQ, CVP) in compliance with FDA, ISO 13485, and GMP regulations.
• Perform risk assessments and gap analyses to ensure validation requirements are met.
• Conduct validation activities for autoclaves, cleanrooms, sterilization cycles (ethylene oxide, gamma, steam), and CIP/SIP systems.
• Lead cleaning validation efforts, including residue analysis, recovery studies, and acceptance criteria development.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to ensure validation strategies align with product and process requirements.
• Generate technical reports, validation master plans (VMPs), and final summary reports.
• Provide support during FDA inspections and audits related to validation activities.
• Identify process improvements and troubleshoot validation deviations.

Required Skillset

Qualifications:

• 5-10 years of experience in sterile and cleaning validation within a medical device, biotech, or pharmaceutical environment.
• In-depth knowledge of FDA regulations, ISO 13485, 21 CFR Part 820, EU MDR, and GMP.
• Strong expertise in sterilization validation methods (EtO, gamma, steam, dry heat).
• Hands-on experience with cleaning validation, TOC analysis, and bioburden reduction strategies.
• Excellent technical writing skills for validation protocols and reports.
• Ability to work independently on the manufacturing floor and collaborate cross-functionally.
• Experience with Kaye Validator or similar advanced validation software (AVS) is a plus.

Preferred Qualifications

• Experience with MasterControl or other QMS platforms.
• Prior involvement in equipment validation for laboratory and production environments.
• Understanding of combination product regulations (if applicable).

Thanks,

Raja