TOLMAR Inc. Process Development Engineer II 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. Provides support in developing and recommending newprocess technologies to achieve improved product quality and costeffectivenessEssential Duties and ResponsibilitiesWork with formulation team to develop manufacturing processes for newproducts.Help make process design decisions, provide input and recommendations.Perform scale-up activities to increase batch size from laboratory to clinicalscale, and from clinical to commercial scale.Write protocols, reports, SOPs, user requirement specifications,laboratory notebook studies, and other controlled documents.Help execute process validation protocols and write validation reports.Interface with equipment vendors to specify equipment, request quotes andorder equipment.Design and execute process development studies and experiments to understandand improve processes.Develop cleaning processes and perform cleaning validation.Coordinate activities for production of clinical batches, "hands on"execution of development and clinical batches.Train manufacturing personnel in technical manufacturing processes.Experience of successful interfacing with Formulation Development,Regulatory, Facilities, Manufacturing, Validation, Quality and variousdepartments for product development.Participate 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 CP 030-0202Chemical Spill Response.Perform other related duties as assigned.Knowledge, Skills and AbilitiesKnowledge of pharmaceutical process development, scale-up and validation.Understanding of cGMP requirements to produce the documentation necessary formanufacturing development batches within a GMP environment.Mechanical aptitude and ability to operate equipment.Knowledge of pharmaceutical manufacturing operations and specialty injectableproducts is desirable, but not required.Effective technical writing skills (batch records, protocols, etc.)Must be able to work in a fast-paced, changing work environment, possessgood time management skills, and exhibit personal responsibility.Effective interpersonal communication skills.Ability to analyze complex problems and implement creative solutions.Ability to learn new technology/new products quickly.Ability to work independently, as well as cooperatively on a team.Ability to manage multiple projects and prioritize/reprioritize work.Positive attitude and willingness to perform labor-intensive work whennecessary. Core ValuesThe Process Development Engineer II is expected to operate within theframework of Tolmar's Core Values:Consistently operate with the highest standards of ethics and compliance.Take ownership of your actions, success and setbacks.Respect each other and understand that honest collaboration is at the heart ofour company success.Go the extra mile to make things happen.Be committed to all we do and the patients we serve.Embrace change with enthusiasm.Strive to learn about and understand the needs of customers and patients,and take action with great speed and efficiency no matter the task. Education and ExperienceBachelor of Science in Chemical Engineering or other Engineering discipline.Degrees in other scientific discipline may be considered.Three or more years' experience in product and/or process development inthe Pharmaceutical/Biotech industry. Working ConditionsWorking conditions are in an office, laboratory and pharmaceuticalmanufacturing environment.Work may require occasional weekend and/or evening work.Work may require lifting objects up to 25 lbs. and use of a respirator.