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Aseptic Process Engineer/Lead
hace 4 semanas
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.
Conducts and writes formal investigation reports with the assistance of plant personnel.
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).