
Aseptic Process Engineer/Lead
hace 4 días
Aseptic Process Engineer/Lead to design and support the aseptic manufacturing processes at designated locations.
Responsible for supporting the planning, execution, tracking, and completion of key aseptic related projects such as but not limited to: Production process/systems implementation, shut down/restart process, media fill oversight, deviation investigations and change management. Able to work cross-functionally with Quality, Operation, Maintenance, Validation, and Sterility Assurance to deliver key milestones for projects.
Responsibilities:
Responsible for technical support of formulation, aseptic filling and sealing operations.
Leads and supports Aseptic process simulations.
Requisitos:
Bachelors Degree in a technical field required. Minimum of 5 years experience in aseptic pharmaceutical manufacturing and/or quality environment required.
Requires thorough knowledge of GMPs and understanding in aseptic processing.
Bilingual (Spanish/English).
Must have the ability to handle multiple projects in a dynamic environment.
Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an aseptic standpoint.
Working knowledge of 21CFR part 211 FDA regulations.
Knowledge of various quality and root cause analysis tools.
Prior investigation writing experience (with determination of product impact).
MS Office (strong knowledge).
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