{"schemaVersion":"jobsearcher.job.v1","id":"7b272b60fe1eaf5c67cae03b","url":"https://jobsearcher.com/jobs/7b272b60fe1eaf5c67cae03b","canonicalUrl":"https://jobsearcher.com/jobs/7b272b60fe1eaf5c67cae03b","title":"Process Development Engineer II (Onsite)","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.\nEssential Duties & Responsibilities\nCollaborate with formulation team to develop and improve manufacturing processes for new and existing products.\nConduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new sterile products.\nInterface with equipment vendors to specify equipment, request quotes and order equipment.\nWrite protocols, reports, batch records, procedures and other controlled documentation.\nDevelop and perform process validation and write validation reports.\nDevelop cleaning processes and perform cleaning validation.\nProvide hands-on execution of engineering studies and manufacture of clinical trial batches.\nUnderstand cGMP requirements and collaborate with Quality Assurance, Validation and Regulatory to ensure compliance.\nExperience with Quality-by-Design (QbD) utilizing Design of Experiments (DoE); development of Risk Assessments and Critical Process Parameters (CPPs).\nProvide technical training to manufacturing employees.\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.\nPerform various other duties as assigned.\nKnowledge, Skills & Abilities\nKnowledge of pharmaceutical manufacturing processes and systems.\nExperience with aseptic processing practices and thorough knowledge of requirements for working in aseptic manufacturing environments.\nKnowledge of FDA guidelines and cGMP requirements.\nExcellent professional written and verbal communication and interpersonal skills.\nHigh attention to detail and sense of personal responsibility.\nAbility to manage multiple projects and prioritize/reprioritize work.\nAbility to work independently with minimal supervision as well as cooperatively on a team.\nExcellent ability to analyze complex development problems and provide creative solutions.\nCore Values\nThe Process Development Engineer II is expected to operate within the framework of Tolmar’s Core Values:\nConsistently operate with the highest standards of ethics and compliance.\nTake ownership of your actions, success and setbacks.\nRespect each other and understand that honest collaboration is at the heart of our company success.\nGo the extra mile to make things happen.\nBe committed to all we do and the patients we serve.\nEmbrace change with enthusiasm.\nStrive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.\nEducation & Experience\nBachelor’s Degree in Chemical Engineering or other scientific discipline plus equivalent engineering experience.\nFive or more years’ experience in Product and/or Process Development in the Pharmaceutical/Biotech industry.\nCompensation and Benefits\nAnnual pay range $80,000 - $87,000\nBenefits information: https://www.tolmar.com/careers/employee-benefits\nTolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.\nWorking Conditions\nWorking conditions are in an office, laboratory and manufacturing environment.\nWork may require occasional weekend and/or evening work.\nWork may require lifting objects up to 25 lbs. and use of a respirator.\nEducation\nRequired\nBachelors or better in Engineering or related field\nEqual Opportunity Employer/Protected Veterans/Individuals with Disabilities\nThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)","company":"Tolmar7","rawCompany":"tolmar7","city":"Windsor","state":"CO","isRemote":false,"isActive":false,"createdAt":"2026-04-12T20:34:52.577Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"}],"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 (Onsite)","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.\nEssential Duties & Responsibilities\nCollaborate with formulation team to develop and improve manufacturing processes for new and existing products.\nConduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new sterile products.\nInterface with equipment vendors to specify equipment, request quotes and order equipment.\nWrite protocols, reports, batch records, procedures and other controlled documentation.\nDevelop and perform process validation and write validation reports.\nDevelop cleaning processes and perform cleaning validation.\nProvide hands-on execution of engineering studies and manufacture of clinical trial batches.\nUnderstand cGMP requirements and collaborate with Quality Assurance, Validation and Regulatory to ensure compliance.\nExperience with Quality-by-Design (QbD) utilizing Design of Experiments (DoE); development of Risk Assessments and Critical Process Parameters (CPPs).\nProvide technical training to manufacturing employees.\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.\nPerform various other duties as assigned.\nKnowledge, Skills & Abilities\nKnowledge of pharmaceutical manufacturing processes and systems.\nExperience with aseptic processing practices and thorough knowledge of requirements for working in aseptic manufacturing environments.\nKnowledge of FDA guidelines and cGMP requirements.\nExcellent professional written and verbal communication and interpersonal skills.\nHigh attention to detail and sense of personal responsibility.\nAbility to manage multiple projects and prioritize/reprioritize work.\nAbility to work independently with minimal supervision as well as cooperatively on a team.\nExcellent ability to analyze complex development problems and provide creative solutions.\nCore Values\nThe Process Development Engineer II is expected to operate within the framework of Tolmar’s Core Values:\nConsistently operate with the highest standards of ethics and compliance.\nTake ownership of your actions, success and setbacks.\nRespect each other and understand that honest collaboration is at the heart of our company success.\nGo the extra mile to make things happen.\nBe committed to all we do and the patients we serve.\nEmbrace change with enthusiasm.\nStrive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.\nEducation & Experience\nBachelor’s Degree in Chemical Engineering or other scientific discipline plus equivalent engineering experience.\nFive or more years’ experience in Product and/or Process Development in the Pharmaceutical/Biotech industry.\nCompensation and Benefits\nAnnual pay range $80,000 - $87,000\nBenefits information: https://www.tolmar.com/careers/employee-benefits\nTolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.\nWorking Conditions\nWorking conditions are in an office, laboratory and manufacturing environment.\nWork may require occasional weekend and/or evening work.\nWork may require lifting objects up to 25 lbs. and use of a respirator.\nEducation\nRequired\nBachelors or better in Engineering or related field\nEqual Opportunity Employer/Protected Veterans/Individuals with Disabilities\nThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)","datePosted":"2026-04-12T20:34:52.577Z","dateModified":"2026-04-12T20:34:52.577Z","hiringOrganization":{"@type":"Organization","name":"Tolmar7","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Windsor","addressRegion":"CO","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"7b272b60fe1eaf5c67cae03b"},"url":"https://jobsearcher.com/jobs/7b272b60fe1eaf5c67cae03b"}}