What are the responsibilities and job description for the Senior Validation Engineer position 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 :
Preferred Qualifications :
Thanks,
Raja
