Process Engineer Technical Operation

Responsibilities: Perform Tech Transfer activities for CMO products with minimum guidelines specifically for liquid, powder filling, soft gel and semi solid that consist of designing, planning, conducting review of pre-formulation, formulation, and process development activities as well as scale-up trials.Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products. Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental and validation protocols are met.Write and execute experimental and validation reports as per related SOPs and assure that acceptance criterion related to experimental and validation reports are met.Initiate change control for new products, site transfer products and changes related to the process improvement with appropriate justification. Lead investigations, write investigation reports with appropriate scientific understanding, as required upon failures to meet protocol acceptance criteria.Author and review investigation reports, protocols, batch records and CMC documentation.Lead projects by use of appropriate project management tools, provide timely updates to management on the status of various projects.Lead and execute material changes, process changes and cost reduction projects.Performs other related duties as assigned.Provide technical training and assistance to others.Requirements:A Bachelor’s in Chemical Engineering preferred.Experience with manufacturing liquid, cream, gel, powder filling, soft gel etc preferred.Proficiency with statistics (using Minitab) preferred.Experience using Excel for data mining and analysis is must.

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Process Engineer Technical Operation

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Process Engineer Technical Operation

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.