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Process Engineer - Pharmaceuticals

Company: Company Confidential
Location: Hickory
Posted on: September 10, 2019

Job Description:

General Requirements Compliance with applicable standard operating procedures Compliance with company environmental health and safety procedures Protect and preserve physical property and equipment Protect and preserve intellectual property and confidential information Education and Work Experience Requirements BS in chemical engineering, biochemistry, chemistry or equivalent physical science 8+ years of experience in pharmaceutical/biotechnology industry, including 5+ years of supervisory experience in sterile drug product formulation/down-stream process development Specific Job Requirements The mission of the Manufacturing, Science, and Technology team is to continuously improve the compliance, efficiency, and strategic position of the site in harmony with global initiatives by applying technical, quality, and scientific principles to innovatively meet patient needs.  The core functions of MS&T include product characterization and analysis, product/process development, technology transfers, scale-down/at-scale process troubleshooting, and root cause analysis. Job Task(s) In collaboration with Manufacturing, Quality, Validations, and Regulatory, ensure the robustness of manufacturing processes so that all site products are validated and remain in constant state of control throughout the product life cycle Provide scientific and technical expertise in the development and validation of new manufacturing operations for API/upstream processing and downstream processing, including transitioning of research techniques into cGMP production methods, to meet quality and regulatory standards. Develop strategies for scale-down/scale-up and characterization of manufacturing processes Lead process development team and operations personnel in process optimization and validation activities for existing unit operations in upstream/downstream processing; including the development, review, and approval feasibility/DoE studies and reports, analytical data summaries and reports, SOPs, master batch records, validation protocols, project summary reports, change controls, and regulatory filings. Effectively communicate scientific and technical concepts, project objectives and vision, and data analysis and conclusions across business units and global sites. Build and maintain relationships, and promote collaboration and cross-functional teamwork to achieve mutual goals. Understand and apply the business side of science i.e. cost of acquisitions, return on investments, development of new processes and technologies; Prepare annual operational and capital budgets including staffing, equipment, reagents and supplies and costs associated with process development, manufacturing, and testing. Understand and apply statistics, Design of Experiments (DoE), Quality by Design (QbD), Process Analytical Technologies (PAT) and lean Six Sigma tools Maintain team training in process development, quality/industry standards, GMPs, GLPs, and six sigma methodologies Computer Skill(s) To perform this job successfully, an individual should have knowledge of MS Office Suite, project management software (i.e. MS Project), ERP systems (i.e. JD Edwards), and statistical software (i.e. Minitab, JMP)

Keywords: Company Confidential, Hickory , Process Engineer - Pharmaceuticals, Other , Hickory, North Carolina

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