{"schemaVersion":"jobsearcher.job.v1","id":"3fbfc47285b1045f8fa7e13b","url":"https://jobsearcher.com/jobs/3fbfc47285b1045f8fa7e13b","canonicalUrl":"https://jobsearcher.com/jobs/3fbfc47285b1045f8fa7e13b","title":"Manufacturing Technical Services Representative","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.\nOur 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.\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? Because we:\nMake it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.\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.\nMake it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.\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:\nThe Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.\n\nThe responsibilities:\nOwner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs\nReview and release commercial batch records to production for execution\nTrain manufacturing personnel on new and/or significant changes to MBRs\nInvestigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)\nAuthors technical studies in support of investigations or process improvements\nOwn change controls and associated tasks\nApprove project related Bill of Materials\nCommercial contact for assigned internal and external clients\nManages client project updates and reviews with all levels of management\nParticipate (with assistance) in Business Review Meetings\nPartner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information\nParticipate on client calls and on-site visits to discuss projects and issue resolutions\nParticipate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations\nEvaluates non-conformance situations for product impact and responsible for advising if product meets release criteria\nUse knowledge of manufacturing systems and equipment to write batch record and perform other duties\nUnderstands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product\n\nRequired qualifications:\nBS degree, preferably in a science-related field\nFamiliar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality\nStrong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization\nStrong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently\nIntermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)\nAbility to use enterprise software (i.e., JDE, Trackwise, etc.)\nAbility to qualify for Grade C areas\n\nPhysical / safety requirements:\nDuties may require overtime work, including nights and weekends\nPosition may require sitting or standing for long periods of time\nAbility to qualify for Grade C areas\n\nIn return, you'll be eligible for [1]:\nDay One Benefits\nMedical & Dental Coverage\nFlexible Spending Accounts\nLife and AD&D Insurance\nSupplemental Life Insurance\nSpouse Life Insurance\nChild Life Insurance\n401(k) Retirement Savings Plan with Company Match\nTime Off Program\nPaid Holidays\nPaid Time Off\nPaid Parental Leave and more\nAdoption Reimbursement Program\nEducation Assistance Program\nEmployee Assistance Program\nCommunity and Volunteer Service Program\nAdditional Benefits\nShort and Long-Term Disability Insurance\nVoluntary Insurance Benefits\nVision Coverage\nAccident\nCritical Illness\nHospital Indemnity Insurance\nIdentity Theft Protection\nLegal and more\nOnsite Campus Amenities\nWorkout Facility\nCafeteria\nCredit Union\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/","company":"Simtrabiopharmasolutions","rawCompany":"simtrabiopharmasolutions","city":"Bloomington","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-08-04T18:44:39.888Z","occupations":[{"code":"41-4011.00","title":"Sales Representatives, Wholesale and Manufacturing, Technical and Scientific Products","slug":"sales-representatives-wholesale-and-manufacturing-technical-and-scientific-products"},{"code":"41-4012.00","title":"Sales Representatives, Wholesale and Manufacturing, Except Technical and Scientific Products","slug":"sales-representatives-wholesale-and-manufacturing-except-technical-and-scientific-products"},{"code":"17-3026.00","title":"Industrial Engineering Technologists and Technicians","slug":"industrial-engineering-technologists-and-technicians"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"325413","title":"In-Vitro Diagnostic Substance Manufacturing","slug":"in-vitro-diagnostic-substance-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Manufacturing Technical Services Representative","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.\nOur 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.\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? Because we:\nMake it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.\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.\nMake it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.\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:\nThe Manufacturing Technical Services Representative is a member of the core client team and interacts directly with clients. The Manufacturing Technical Services Representative is responsible for technical and process improvement aspects of the project. This position is 100% onsite at the Bloomington facility and reports to the Manager, Manufacturing Technical Services.\n\nThe responsibilities:\nOwner and technical expert of commercial master batch records (MBR) for assigned projects - author, maintain and revise MBRs\nReview and release commercial batch records to production for execution\nTrain manufacturing personnel on new and/or significant changes to MBRs\nInvestigate Non-Conformance Report (NCR) and determine root cause to assign/own the corrective action(s)\nAuthors technical studies in support of investigations or process improvements\nOwn change controls and associated tasks\nApprove project related Bill of Materials\nCommercial contact for assigned internal and external clients\nManages client project updates and reviews with all levels of management\nParticipate (with assistance) in Business Review Meetings\nPartner with Program Management, Quality Assurance Associates, Quality Control Representative, and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information\nParticipate on client calls and on-site visits to discuss projects and issue resolutions\nParticipate (with assistance) in regulatory, client and internal audits as a product/process Subject Matter Expert (SME) and own the responses for observations\nEvaluates non-conformance situations for product impact and responsible for advising if product meets release criteria\nUse knowledge of manufacturing systems and equipment to write batch record and perform other duties\nUnderstands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product\n\nRequired qualifications:\nBS degree, preferably in a science-related field\nFamiliar with quality operating procedures, quality and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality\nStrong communication skills, both written and verbal, with the ability to interact with many functions and levels across the organization\nStrong organizational skills, attention to detail, and collaboration skills with the ability to meet tight deadlines and manage multiple projects concurrently\nIntermediate proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook)\nAbility to use enterprise software (i.e., JDE, Trackwise, etc.)\nAbility to qualify for Grade C areas\n\nPhysical / safety requirements:\nDuties may require overtime work, including nights and weekends\nPosition may require sitting or standing for long periods of time\nAbility to qualify for Grade C areas\n\nIn return, you'll be eligible for [1]:\nDay One Benefits\nMedical & Dental Coverage\nFlexible Spending Accounts\nLife and AD&D Insurance\nSupplemental Life Insurance\nSpouse Life Insurance\nChild Life Insurance\n401(k) Retirement Savings Plan with Company Match\nTime Off Program\nPaid Holidays\nPaid Time Off\nPaid Parental Leave and more\nAdoption Reimbursement Program\nEducation Assistance Program\nEmployee Assistance Program\nCommunity and Volunteer Service Program\nAdditional Benefits\nShort and Long-Term Disability Insurance\nVoluntary Insurance Benefits\nVision Coverage\nAccident\nCritical Illness\nHospital Indemnity Insurance\nIdentity Theft Protection\nLegal and more\nOnsite Campus Amenities\nWorkout Facility\nCafeteria\nCredit Union\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/","datePosted":"2026-08-04T18:44:39.888Z","dateModified":"2026-08-04T18:44:39.888Z","hiringOrganization":{"@type":"Organization","name":"Simtrabiopharmasolutions","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bloomington","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"3fbfc47285b1045f8fa7e13b"},"url":"https://jobsearcher.com/jobs/3fbfc47285b1045f8fa7e13b"}}