TOLMAR Inc. Process Development Engineer I in Windsor, Colorado
Purpose and ScopeAssists with the design and implementation of manufacturing processes,instrumentation and equipment from the laboratory through pilot plant andmanufacturing scale-up. Assists the manufacturing operation in problem solvingwith regards to equipment and systems.Essential Duties and Responsibilities Assist other Process Development Engineers as needed to refine batchrecords, implementing changes when necessary to address manufacturingconsiderations including processing, manufacturability and scale-up. Understand and improve process and equipment by working with formulationscientists, other engineers, or manufacturing personnel. Conduct lab studies and scale up evaluations. Help identify new equipment and components and solicit prices and quotesfrom vendors. Update procedures and other controlled documents using change controlprocess. Help execute development engineering batches under GMP conditions, helpdevelop cleaning protocols, oversee execution of validation protocols. Help write numerous documents - protocols, specifications,reports, procedures, equipment qualification protocols, etc. Participates in required annual hazardous waste training. Hazardous wasteinvolvement may include but is not limited to container and tank managementand inspections, generation of hazardous waste as a part of production orsampling processes, and transfer of hazardous waste between lab procedurearea, satellite accumulation, and storage. Respond to spills per CP030-0202 Chemical Spill Response. Perform other related duties as assigned.Knowledge, Skills and Abilities Knowledge of FDA guidelines and cGMP Procedures. Knowledge of chemistry, engineering principles, and pharmaceutical industry. Good documentation practice and technical writing ability. Working knowledge of spreadsheets and word processing. Effective written and oral communication skills. Ability to analyze complex development problems, propose and implementcreative solutions. Ability to work independently with minimal supervision as well ascooperatively on a team. Ability to manage multiple projects and prioritize/reprioritize work.Requirements Education and Experience B.S. in an engineering discipline, chemical or mechanical engineeringpreferred. Degrees in other scientific discipline may be considered. One or more years' experience in an engineering environment.