{"schemaVersion":"jobsearcher.job.v1","id":"3368fb2cab802117a8473952","url":"https://jobsearcher.com/jobs/3368fb2cab802117a8473952","canonicalUrl":"https://jobsearcher.com/jobs/3368fb2cab802117a8473952","title":"Process Development Engineer II - Part-time 20 hours","description":"Purpose and Scope\nPerforms the design and implementation of aseptic manufacturing processes, instrumentation, and equipment for product technical transfer to commercial manufacturing scale-up. Provides support for existing commercial products/processes when needed. Develops and recommends new process technologies to achieve improved product quality and cost effectiveness.\n\nEssential Duties & Responsibilities\n\nCollaborate with the formulation team to develop and improve manufacturing processes for new and existing products.\n\nConduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new sterile products.\n\nInterface with equipment vendors to specify equipment, request quotes and order equipment.\n\nWrite protocols, reports, batch records, procedures, and other controlled documentation.\n\nDevelop and perform process validation and write validation reports.\n\nDevelop cleaning processes and perform cleaning validation.\n\nProvide hands‑on execution of engineering studies and manufacture of clinical trial batches.\n\nUnderstand cGMP requirements and collaborate with Quality Assurance, Validation and Regulatory to ensure compliance.\n\nExperience with Quality‑by‑Design (QbD) utilizing Design of Experiments (DoE); development of Risk Assessments and Critical Process Parameters (CPPs).\n\nProvide technical training to manufacturing employees.\n\nParticipate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.\n\nPerform various other duties as assigned.\n\nKnowledge, Skills & Abilities\n\nKnowledge of pharmaceutical manufacturing processes and systems.\n\nExperience with aseptic processing practices and thorough knowledge of requirements for working in aseptic manufacturing environments.\n\nKnowledge of FDA guidelines and cGMP requirements.\n\nExcellent professional written and verbal communication and interpersonal skills.\n\nHigh attention to detail and sense of personal responsibility.\n\nAbility to manage multiple projects and prioritize/reprioritize work.\n\nAbility to work independently with minimal supervision as well as cooperatively on a team.\n\nExcellent ability to analyze complex development problems and provide creative solutions.\n\nEducation & Experience\n\nBachelor’s degree in chemical engineering or other scientific discipline plus equivalent engineering experience.\n\nThree or more years’ experience in Product and/or Process Development in the Pharmaceutical/Biotech industry.\n\nWorking Conditions\n\nWorking conditions are in an office, laboratory and manufacturing environment.\n\nWork may require occasional weekend and/or evening work.\n\nWork may require lifting objects up to 25 lbs. and use of a respirator.\n\nCompensation and Benefits\n\nHourly rate: $45.00 hr\n\nBenefits information: https://www.tolmar.com/careers/employee-benefits\n\nPlease note that due to the temporary and part‑time nature of the position, not all benefits may apply.\n\nTolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job‑related factors.\n\n#J-18808-Ljbffr","company":"Cobioscience","rawCompany":"cobioscience","city":"Windsor","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-06-17T03:44:01.248Z","occupations":[{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2199.00","title":"Engineers, All Other","slug":"engineers-all-other"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Development Engineer II - Part-time 20 hours","description":"Purpose and Scope\nPerforms the design and implementation of aseptic manufacturing processes, instrumentation, and equipment for product technical transfer to commercial manufacturing scale-up. Provides support for existing commercial products/processes when needed. Develops and recommends new process technologies to achieve improved product quality and cost effectiveness.\n\nEssential Duties & Responsibilities\n\nCollaborate with the formulation team to develop and improve manufacturing processes for new and existing products.\n\nConduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new sterile products.\n\nInterface with equipment vendors to specify equipment, request quotes and order equipment.\n\nWrite protocols, reports, batch records, procedures, and other controlled documentation.\n\nDevelop and perform process validation and write validation reports.\n\nDevelop cleaning processes and perform cleaning validation.\n\nProvide hands‑on execution of engineering studies and manufacture of clinical trial batches.\n\nUnderstand cGMP requirements and collaborate with Quality Assurance, Validation and Regulatory to ensure compliance.\n\nExperience with Quality‑by‑Design (QbD) utilizing Design of Experiments (DoE); development of Risk Assessments and Critical Process Parameters (CPPs).\n\nProvide technical training to manufacturing employees.\n\nParticipate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.\n\nPerform various other duties as assigned.\n\nKnowledge, Skills & Abilities\n\nKnowledge of pharmaceutical manufacturing processes and systems.\n\nExperience with aseptic processing practices and thorough knowledge of requirements for working in aseptic manufacturing environments.\n\nKnowledge of FDA guidelines and cGMP requirements.\n\nExcellent professional written and verbal communication and interpersonal skills.\n\nHigh attention to detail and sense of personal responsibility.\n\nAbility to manage multiple projects and prioritize/reprioritize work.\n\nAbility to work independently with minimal supervision as well as cooperatively on a team.\n\nExcellent ability to analyze complex development problems and provide creative solutions.\n\nEducation & Experience\n\nBachelor’s degree in chemical engineering or other scientific discipline plus equivalent engineering experience.\n\nThree or more years’ experience in Product and/or Process Development in the Pharmaceutical/Biotech industry.\n\nWorking Conditions\n\nWorking conditions are in an office, laboratory and manufacturing environment.\n\nWork may require occasional weekend and/or evening work.\n\nWork may require lifting objects up to 25 lbs. and use of a respirator.\n\nCompensation and Benefits\n\nHourly rate: $45.00 hr\n\nBenefits information: https://www.tolmar.com/careers/employee-benefits\n\nPlease note that due to the temporary and part‑time nature of the position, not all benefits may apply.\n\nTolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job‑related factors.\n\n#J-18808-Ljbffr","datePosted":"2026-06-17T03:44:01.248Z","dateModified":"2026-06-17T03:44:01.248Z","hiringOrganization":{"@type":"Organization","name":"Cobioscience","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Windsor","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3368fb2cab802117a8473952"},"url":"https://jobsearcher.com/jobs/3368fb2cab802117a8473952"}}