Sr. Aseptic Process Engineering Manager
hace 1 día
**Aseptic Process Engineer Lead - Drive Excellence in Manufacturing**
Are you a seasoned aseptic process engineer looking to take your career to the next level? Join us at Qrc Group, Llc, where we strive for excellence in manufacturing and aseptic processing.
Key Expectations:
- Develop and maintain aseptic processes and systems to ensure compliance with industry standards
- Provide technical expertise for FDA submissions and regulatory affairs initiatives
- Collaborate with cross-functional teams to identify and implement process improvements
- Lead investigations and resolutions for deviations and CAPAs related to aseptic operations
Requirements:
- Bachelor's or Master's Degree in Engineering, Pharmaceutical Sciences, or a related field
- Minimum of 5-7 years of experience in aseptic process engineering, equipment validation, and FDA product submissions within a regulated pharmaceutical or biotech environment
- Strong knowledge of aseptic processing and systems (e.g., filling lines, isolators, lyophilizers)
- Expertise in validation methodologies (IQ/OQ/PQ) and risk management
- Familiarity with FDA regulations, cGMP guidelines, and industry standards (e.g., ISO)
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