Project Engineer - Aseptic Compounding Specialist
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The Innovative Medicine Supply Chain is seeking a Project Engineer to lead engineering projects within a pharmaceutical manufacturing environment. The successful candidate will be responsible for scoping and leading projects, ensuring project scope, priorities, resources, capabilities, and processes are clearly defined and in place.
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This role involves aligning with project sponsors and bringing together core and extended teams to deliver final project objectives. The Project Engineer will prepare project intake documentation, including scope definition, business case analysis, alternatives assessment, and presentation of the recommended option for approval.
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The ideal candidate will have a solid background in aseptic processing and experience with risk-based qualification methodologies. They will also have excellent project management skills, including the ability to facilitate project planning, monitoring, and reporting against key deliverables and objectives.
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In this role, you will oversee all technical engineering activities from conceptual design through construction and qualification, including coordination with internal resources and external contractors/suppliers. You will identify and manage project risks using appropriate risk management techniques and ensure sound technical engineering practices are applied throughout all phases of the project.
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You will provide regular project updates to stakeholders, including project sponsors, engineering leads, operations, and quality departments. Additionally, you will ensure full compliance with Environmental, Health, Safety, and Sustainability (EHSS) standards.
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Requirements:
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* A technical education/degree in an engineering discipline is required.
* 2–5 years of experience in a relevant field is preferred.
* Experience in a GMP-regulated environment is a plus.
* Solid background in aseptic processing is highly desirable.
* Experience with risk-based qualification methodologies is an advantage.
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