Position Details
About this role
Leads quality assurance processes related to validation and qualification of manufacturing equipment and processes, ensuring compliance with regulatory standards in a pharmaceutical or medical device environment.
Key Responsibilities
- Develop validation protocols
- Conduct qualification testing
- Ensure compliance with FDA standards
- Support regulatory inspections
- Maintain quality system
Technical Overview
Involves validation protocols, equipment and software qualification, cGMP compliance, and FDA regulation adherence within a pharmaceutical/medical device setting.
Ideal Candidate
The ideal candidate is a senior quality engineer with 2+ years of experience in validation, familiar with cGMP, FDA regulations, and equipment/software qualification processes, capable of leading validation protocols and supporting regulatory inspections.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of validation experience, No familiarity with FDA or cGMP standards, Inability to develop validation protocols
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