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Job Description |
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Senior Process Engineer
Description |
Reporting to Director, Engineering, the Senior Process Engineer will be responsible for implementation of projects for the manufacture of APIs and bulk intermediates and other products from development through piloting and/or commercial production.
Job Responsibilities
Identifying and executing improvements to existing products to achieve improved yields, quality or customer expectations
Overseeing personnel engaged in the activity of producing the products in pilot and commercial production areas
Working in a team environment and assuming a team leadership role as necessary that includes cross-departmental participation from Engineering, Research and Development, Regulatory, Quality Control, Analytical Development and Operations
Coordinating the activities of different functional groups to expedite execution and timely completion of new production introductions and process improvements
Developing plans for production of pilot and commercial volumes of product
Developing and maintaining IQ, OQ and PQ documents and protocols
Writing batch records and cleaning batch records, campaign reports and other miscellaneous reports and documents as needed
Troubleshooting, investigating process problems and deviations, and preparing appropriate reports on findings
Participating in HAZOPs and providing guidance on corrective actions when needed
Developing cost estimates as needed
Providing PFD and P&ID generation, energy balances, material balances, environmental calculations and other calculations and formulations as needed
Job Qualifications
BS in Chemical Engineering required
7 or more years of experience in manufacturing environment, preferably in pharmaceutical or fine chemical manufacture
Knowlege of and/or direct experience in a cGMP environment is preferred
General knowledge of chemical operations equipment and manufacturing operations
Proficient in windows based environment including word processing, spreadsheet and data base programs | |
