What are the responsibilities and job description for the Validation Engineer, Sterile & Cleaning position at Katalyst HealthCares and Life Sciences?
Responsibilities :
- 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.
- 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.
Requirements :
