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Process Engineer

Summit Biosciences Inc.

This is a Full-time position in Lexington, KY posted June 11, 2021.

Summit Biosciences is a fast growing leader in the field of Intranasal Pharmaceuticals.

At Summit Biosciences, we aim to provide and promote an environment of continuous learning and improvement, which leads to and harnesses innovation.

We offer fantastic perks & benefits such as strong compensation w/ bonus program, medical/dental/vision/life/disability insurance, 401k + company match, holidays off, PTO, a family like culture, and much more!

The Process Engineer is responsible for performing and/or leading a wide-array of manufacturing process/equipment development and engineering activities in a pharmaceutical cGMP environment.

These activities include designing studies and processes, writing and executing protocols for testing equipment, product and processes, and summarizing results into reports.

Also assists in troubleshooting, equipment and facility design, and managing commissioning, validation and revalidation projects.

 

Essential Duties:
 Lead projects or participate on project teams to develop the manufacturing process for new products and implement improvements to existing processes to manufacture and package multiple types of nasal spray drug products Assist in the design and procurement of new process and utility equipment and lead installation, start-up, commissioning or qualification activities including authoring IQ/OQ/PQ protocols, test execution, and authoring summary reports Design and execute studies as required to investigate, optimize, troubleshoot, and implement process improvements Work on multiple process development and validation projects simultaneously and coordinate test work with various other departments Participate in the development and implementation of procedural or automation improvement changes Write procedures, protocols and reports for manufacturing, utility, lab equipment, cleaning and process validation Compile validation packages and assure all required documentation is accurate and complete Champion process improvement projects and ensure equipment and systems remain in a qualified state Lead investigations and assure thoroughness of investigation, identification of root cause, documentation and closure Participate in design reviews of plant expansions or process changes, and serve as a technical point of contact or user representative for contract services Point person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols Provide support to Manufacturing, Quality, Maintenance, and Validation for deviation investigations, change controls and CAPA’s through participation on cross functional teams Support Maintenance activities, including review and approval of preventative maintenance tasks, calibration tolerances and intervals, drawing updates, and support of out-of-tolerance investigations related to instrument calibrations Lead risk assessment exercises related to equipment and processes, including Failure Mode Effect Analysis (FMEA).

Train technicians on Production Batch Records.

Assist or conduct investigations to resolve deviations, including Root Cause Analysis (RCA).

Other duties as assigned
 

Qualifications:

 
BS in Chemical Engineering or related life science Minimum of 2-5 years of previous work experience in a related or unrelated field.

Experience providing technical support in a cGMP manufacturing environment including hands-on product development, optimization and troubleshooting of equipment and processes is preferred Excellent working knowledge of cGMPs and regulatory requirements is preferred Excellent technical writing and organizational skills; extremely detail oriented Good mechanical aptitude Good interpersonal skills and the ability to work well in a team environment Self-starting with outstanding work ethic; must be able to perform in a fast paced multi-product environment Ability to maintain focus on tasks until completion and think analytically to solve problems when appropriate.

Ability to apply statistics and process capability methodologies to evaluate processes and to implement and monitor improvements Strong listening, writing, reading, and verbal communication skills