LEAD ASEPTIC PROCESS ENGINEER
hace 1 día
**Unlock Your Potential as an Aseptic Process Engineer Lead**
Join our team at Qrc Group, Llc, where innovation meets expertise in aseptic processing and manufacturing. As our Sr. Aseptic Process Engineer, you will lead the way in delivering high-quality products that meet regulatory requirements.
What We Offer:
- Opportunity to work on challenging projects and collaborate with cross-functional teams
- Professional growth and development in a dynamic and supportive environment
- Competitive salary and benefits package
Responsibilities:
- Develop and implement aseptic processes and systems to ensure compliance with industry standards
- Provide technical expertise for FDA submissions and support regulatory affairs initiatives
- Collaborate with internal stakeholders to design and implement process improvements
- Investigate and resolve 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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