Regulated Pharmaceutical Engineering Expert
hace 1 día
We are looking for an experienced Sr. Engineer to join our team at Qrc Group Llc and lead the design, implementation, and improvement of aseptic processes and systems.
Responsibilities:
- Design and develop aseptic processes and systems that meet regulatory requirements and industry standards.
- Lead cross-functional teams to ensure compliance with regulatory requirements and industry standards.
- Investigate and resolve issues related to aseptic operations.
- Support FDA submissions by providing technical expertise and documentation for aseptic processing and equipment validation activities.
Qualifications:
- 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 environment.
- Strong knowledge of aseptic processing and systems.
- Expertise in validation methodologies (IQ/OQ/PQ) and risk management.
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