Process Engineer (Active Pharmaceutical Ingredient)
Responsibilities:
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Responsible for manufacturing process technical support and improvement initiatives for ongoing operations
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Support start-up and assist in plant equipment and facility validation and qualification activities
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Supports manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site
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Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s
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Contact and consultant for process/equipment troubleshooting and investigation activities
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Supports risk assessment activities providing relevant technical knowledge
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Provides support for process cleaning/changeover strategies
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Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation
About You:
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Chemical Engineering with >5 years of experience in the area of API Manufacturing (Process Engineer) or Manufacturing, Science and Technology (MSAT) role
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Responsible for manufacturing support of commercial API processes for small chemical molecules
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Provides rapid response to operational issues and supports ongoing operations including new product introduction, process engineer, process flow diagrams and process batch record authoring