{"schemaVersion":"jobsearcher.job.v1","id":"0c32534116c0826cd0d96d95","url":"https://jobsearcher.com/jobs/0c32534116c0826cd0d96d95","canonicalUrl":"https://jobsearcher.com/jobs/0c32534116c0826cd0d96d95","title":"Process Engineer","description":"Simtra BioPharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.\n\nWhile our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life‑changing medicines to patients worldwide.\n\nWhy join Team Simtra?\nMake it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.\n\nMake it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.\n\nMake it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.\n\nMake it COUNT – We take pride in our day‑to‑day work, knowing the impact we make – taking on challenges big and small to improve patient health.\n\nThis role\nWe are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross‑functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.\n\nResponsibilities\n\nDemonstrates a strong ownership for the equipment and processes in the filling or packaging areas\n\nImplement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes\n\nDevelop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment\n\nAuthor and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems\n\nCollaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design\n\nDevelop and maintain project schedules using MS Project\n\nCollaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met\n\nProvide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment\n\nInteract with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders\n\nSupport with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence\n\nRequired qualifications\n\nBS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field\n\n1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)\n\n0‑2 years of experience (Level I)\n\n2‑5 years of experience (Level II)\n\n5‑8 years of experience (Level III/Sr.)\n\n8+ years of experience (Level IV/Principal)\n\nKnowledge of the basic principles in aseptic processing and/or packaging engineering best practices\n\nMust be able to lead and execute engineering projects\n\nStrong understanding of packaging materials, processing, and testing methods\n\nExperience with PLC, HMI, Vision Systems and Building Management systems\n\nStrong oral and written communication skills\n\nMust be able to read mechanical, electrical, and P&ID drawings\n\nAutoCAD or equivalent component design knowledge\n\nAdvanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)\n\nExperience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)\n\nPhysical / safety requirements\n\nDuties may require overtime work, including nights and weekends\n\nPosition requires sitting for long hours, but may also involve walking or standing for long periods of time\n\nVariable travel of 0‑10% could be expected\n\nMust be able to lift, push, pull, and carry up to 50 lbs\n\nMust be able to lift 20 lbs overhead\n\nMust be able to wear personal protective equipment (PPE), as required\n\nIn return, you’ll be eligible for\n\nDay One Benefits\n\nMedical & Dental Coverage\n\nFlexible Spending Accounts\n\nLife and AD&D Insurance\n\nSupplemental Life Insurance\n\nSpouse Life Insurance\n\nChild Life Insurance\n\n401(k) Retirement Savings Plan with Company Match\n\nTime Off Program\n\nPaid Holidays\n\nPaid Time Off\n\nPaid Parental Leave and more\n\nAdoption Reimbursement Program\n\nEducation Assistance Program\n\nEmployee Assistance Program\n\nCommunity and Volunteer Service Program\n\nEmployee Ownership Plan\n\nAdditional Benefits\n\nShort and Long‑Term Disability Insurance\n\nVoluntary Insurance Benefits\n\nVision Coverage\n\nAccident\n\nCritical Illness\n\nHospital Indemnity Insurance\n\nIdentity Theft Protection\n\nLegal and more\n\nOnsite Campus Amenities\n\nWorkout Facility\n\nCafeteria\n\nCredit Union\n\n[1] Current benefit offerings are in effect through 12/31/26\n\nDisclaimer\nThis job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.\n\nEqual Employment Opportunity\nSimtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.\n\nData Privacy\nTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/.\n\n#J-18808-Ljbffr","company":"Simtrabps","rawCompany":"simtrabps","city":"Bloomington","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-07-08T03:18:38.532Z","occupations":[{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2041.00","title":"Chemical Engineers","slug":"chemical-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":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Engineer","description":"Simtra BioPharma Solutions (Simtra) is a world‑class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre‑filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder‑filled vials and sterile crystallization. Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.\n\nWhile our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life‑changing medicines to patients worldwide.\n\nWhy join Team Simtra?\nMake it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.\n\nMake it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.\n\nMake it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.\n\nMake it COUNT – We take pride in our day‑to‑day work, knowing the impact we make – taking on challenges big and small to improve patient health.\n\nThis role\nWe are looking for a Process Engineer (level depends on experience) that is responsible for developing, implementing, and optimizing manufacturing packaging processes to improve efficiency, quality, and productivity. This engineer will work closely with cross‑functional teams to identify areas for process improvement, troubleshoot issues, and ensure compliance with safety and regulatory standards in the pharmaceutical aseptic manufacturing or automated inspection & packaging areas. This position is 100% onsite at the Bloomington facility and reports directly to the Sr. Manager, Engineering & Maintenance.\n\nResponsibilities\n\nDemonstrates a strong ownership for the equipment and processes in the filling or packaging areas\n\nImplement process improvement projects that enhance efficiency, improve quality, and reduce costs for aseptic filling processes, lyophilization, or inspection & packaging processes\n\nDevelop user requirements (URS), technical specification and design specifications for new processing (aseptic filling, lyophilization, equipment preparation, formulation) and/or automated inspection & packaging equipment and/or upgrades to existing equipment\n\nAuthor and execute protocols to include commissioning, qualification, and validation activities (FAT, SAT, IQ and OQ) for packaging systems\n\nCollaborates with external engineering firms or OEM in feasibility assessments, concept design, basic design, and detail design\n\nDevelop and maintain project schedules using MS Project\n\nCollaborate with suppliers to source processing and/or packaging equipment parts to ensure quality standards are met\n\nProvide technical support and training to operations and maintenance on aseptic processing equipment or inspection & packaging equipment\n\nInteract with all functions and levels of management, ensuring effective, ongoing communication across teams and internal/external stakeholders\n\nSupport with complex site investigation of key safety and production issues and events and work on the identification and implementation of CAPA (Corrective and Preventive Action) plans to address such events and prevent recurrence\n\nRequired qualifications\n\nBS degree in Engineering (Chemical, Mechanical, Electrical, Packaging, Pharmaceutical, Biomedical), or a related technical field\n\n1+ years of experience in aseptic processes or inspection & packaging engineering in the pharmaceutical industry (level hired for depends on years of experience)\n\n0‑2 years of experience (Level I)\n\n2‑5 years of experience (Level II)\n\n5‑8 years of experience (Level III/Sr.)\n\n8+ years of experience (Level IV/Principal)\n\nKnowledge of the basic principles in aseptic processing and/or packaging engineering best practices\n\nMust be able to lead and execute engineering projects\n\nStrong understanding of packaging materials, processing, and testing methods\n\nExperience with PLC, HMI, Vision Systems and Building Management systems\n\nStrong oral and written communication skills\n\nMust be able to read mechanical, electrical, and P&ID drawings\n\nAutoCAD or equivalent component design knowledge\n\nAdvanced proficiency in Microsoft Office Suite (Word, Excel, and Outlook)\n\nExperience and the ability to use enterprise software (examples include: JDE, Microsoft Dynamics, BPLM, Veeva, Trackwise, etc.)\n\nPhysical / safety requirements\n\nDuties may require overtime work, including nights and weekends\n\nPosition requires sitting for long hours, but may also involve walking or standing for long periods of time\n\nVariable travel of 0‑10% could be expected\n\nMust be able to lift, push, pull, and carry up to 50 lbs\n\nMust be able to lift 20 lbs overhead\n\nMust be able to wear personal protective equipment (PPE), as required\n\nIn return, you’ll be eligible for\n\nDay One Benefits\n\nMedical & Dental Coverage\n\nFlexible Spending Accounts\n\nLife and AD&D Insurance\n\nSupplemental Life Insurance\n\nSpouse Life Insurance\n\nChild Life Insurance\n\n401(k) Retirement Savings Plan with Company Match\n\nTime Off Program\n\nPaid Holidays\n\nPaid Time Off\n\nPaid Parental Leave and more\n\nAdoption Reimbursement Program\n\nEducation Assistance Program\n\nEmployee Assistance Program\n\nCommunity and Volunteer Service Program\n\nEmployee Ownership Plan\n\nAdditional Benefits\n\nShort and Long‑Term Disability Insurance\n\nVoluntary Insurance Benefits\n\nVision Coverage\n\nAccident\n\nCritical Illness\n\nHospital Indemnity Insurance\n\nIdentity Theft Protection\n\nLegal and more\n\nOnsite Campus Amenities\n\nWorkout Facility\n\nCafeteria\n\nCredit Union\n\n[1] Current benefit offerings are in effect through 12/31/26\n\nDisclaimer\nThis job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.\n\nEqual Employment Opportunity\nSimtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.\n\nData Privacy\nTo learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/.\n\n#J-18808-Ljbffr","datePosted":"2026-07-08T03:18:38.532Z","dateModified":"2026-07-08T03:18:38.532Z","hiringOrganization":{"@type":"Organization","name":"Simtrabps","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bloomington","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"0c32534116c0826cd0d96d95"},"url":"https://jobsearcher.com/jobs/0c32534116c0826cd0d96d95"}}