The Role
Leads complex manufacturing engineering projects, line studies, and qualification and validation activities. Develops validation strategies, protocols, reports, sampling plans, and data analyses independently. Provides guidance on validation deviations and complex data interpretation while leading root cause analyses for significant manufacturing events using DMAIC and A3 methodologies.
Summary Generated by Built In
The Senior Manufacturing Engineer will apply scientific knowledge, engineering knowledge, mathematics and ingenuity to lead moderately and/or high complex projects with little to no supervision.
Tasks:
- Runs studies and qualification/validations on the line as needed.
- Writes protocols and reports with no oversight.
- Determines overall validation strategy including validation type/requirements, determination of process outputs, sampling plans and performs data analysis. Provides guidance for validation deviations and complex validation data analysis.
- Leads root cause analysis efforts for high complexity manufacturing events, utilizing DMAIC model and A3s.
Requirements
- Bachelor's Degree Engineering
- Five (5) years of experience
- Bilingual (English/Spanish)
Skills Required
- Bachelor's degree in Engineering
- Five years of experience
- Bilingual in English and Spanish
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
