Senior Process Engineer

DUTIES:  Provide technical support for formulation, including investigation and correction of process-related problems and deviations from standards. Identify and execute projects to reduce product cost, improve product quality, improve yield, and reduce material usage. Design and execute process qualifications and validations for approved changes. Serve as a subject matter expert (“SME”) for technical projects affecting formulation during internal audits and regulatory inspections. Lead technology transfer and implementation of new technologies, equipment, and processes. Enhance quality and effectiveness of manufacturing systems. Develop Product/Process knowledge in multiple product steams and technologies. Lead product scale up activities. Identify, recommend, and implement equipment modifications. Provide technical support for Formulation areas, including investigation and correction of manufacturing technical/quality issues. Conduct statistical process control and process capability analysis for existing products.

REQUIREMENTS:  Must have a Bachelor’s degree or foreign equivalent in Chemical Engineering, Biological Engineering or a related field plus four (4) years of experience in the position offered, as a Process Engineer or in a related position. Must have four (4) years of experience in the pharmaceutical production sector with each of the following: Conducting technology transfers and commercial support of complex oral solid dosage form unit operations in top spray fluid bed granulation, wet granulation, roller compaction, bilayer compression, or multi-tip tablet compression; Implementing continuous improvement and capacity improvement projects within oral solid dosage form manufacturing processes; Designing and executing process qualifications and validations required when implementing improvements; Problem solving and issue investigation using structured problem solving methodologies including DMAIC, PPS, or Kepner-Tregoe; Performing data visualization, data analysis, and data interpretation using statistical software including Minitab, JMP, SAS, or R; Conducting Continued Process Verification for commercial product support in understanding the underlying relationships between raw materials, process parameters, and final critical quality attributes; and Extracting and interpreting data from source systems including SAP, LIMs, PAS-X, OSI-PI, or Manufacturing Data Historians. In the alternative, Employer will accept a Master’s degree in Chemical Engineering, Biological Engineering or a related field plus one (1) year of experience. Employer will accept pre or post MA degree experience. Any combination of education, experience or training is acceptable.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.