Sr. Engineer with expertise in aseptic processing, FDA product submissions, and validation activities within a regulated pharmaceutical environment.
Responsibilities:
Lead efforts in the design, commissioning, implementation, and improvement of aseptic processes and systems to ensure high-quality production and compliance with industry standards (e.g., GMP, FDA, EMA).
Troubleshoot and resolve issues related to aseptic operations, ensuring compliance with cGMP and FDA guidelines.
Support FDA submissions by providing technical expertise and documentation for aseptic processing and equipment validation activities.
Review and prepare technical data for inclusion in regulatory submissions, ensuring compliance with FDA requirements.
Provide input on regulatory requirements and assist in ensuring that products meet regulatory expectations for approval.
Requisitos:
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 manage?ment.
Familiarity with FDA regulations, cGMP guidelines, and industry standards (e.g., ISO).
Experience with process improvement methodologies (e.g., Lean, Six Sigma) is a plus.
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