Katalyst CRO
Validation Engineer, Sterile & Cleaning Job at Katalyst CRO in Bedford
Katalyst CRO, Bedford, MA, United States, 01730
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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.
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.
Requirements:
- 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.
- Experience with MasterControl or other QMS platforms.
- Prior involvement in equipment validation for laboratory and production environments.
- Understanding of combination product regulations (if applicable).
Additional Details:
- Seniority level: Mid-Senior level
- Employment type: Contract
- Industry: Pharmaceutical Manufacturing