Katalysthealthcareslifesciences
Validation Engineer
North Haven, CT, United States · Junior
Sponsorship not specifiedDetected 362 days ago
SAPERPSolidWorksClinical TrialsClinical ResearchGMPFDA RegulatoryPharmacovigilanceMedical DevicesResearch
About the role
- As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world.
- All your information will be kept confidential according to EEO guidelines.
Requirements
- Bachelor's degree with a minimum of 5-7 years of experience in a regulated environment, OR an advanced degree with a minimum of 3 years of experience.
- Minimum of 5 years of professional experience in a relevant field.
- Experience with Agile PLM and SAP or BPCS ERP systems.
- Experience with CAD model with use of Solid works or AutoCAD.
- Experience with NPI and design transfers deliverables for injection moulded components.
- Experience within highly regulated industry.
- Hands on experience within production and enterprise environment.
Benefits
- Developing and executing validation plans, conducting audits, and managing the overall PPAP process to ensure compliance with ISO 13485/ Medical standards.
- Clean Room experience and medical prod mfg exp (added advantage).
Company info
- In this role, you'll facilitate or perform critical validation & qualification activities, ensuring the seamless release of high-quality injection molded components that drive our mission forward.
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