{"schemaVersion":"jobsearcher.job.v1","id":"6ba51bbf4d29af1dc841c437","url":"https://jobsearcher.com/jobs/6ba51bbf4d29af1dc841c437","canonicalUrl":"https://jobsearcher.com/jobs/6ba51bbf4d29af1dc841c437","title":"Process Validation Associate III","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\nThe role:\nThis position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Process Validation Sr. Manager.\n\nThe responsibilities:\nSupport and maintain the process validation program.\nDevelop, revise, and maintain process validation procedures, protocols, and summary reports.\nPartner with clients and internal teams to define validation scope, requirements, and objectives.\nDesign, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.\nPerform risk assessments to support process validation activities.\nPlan, coordinate, and execute process validation activities for new and existing products.\nAnalyze validation data and prepare documentation to support validation conclusions.\nConduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.\nLead or support investigations related to validation activities, including Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).\nMonitor regulatory requirements and industry best practices to ensure compliance and continuous improvement.\nCreate and maintain visual management tools and controls for the Process Validation group.\nServe as a Subject Matter Expert (SME) for process validation during regulatory, client, and internal audits.\nDevelop industry expertise and project proficiency while working independently on assigned initiatives.\nIdentify and implement opportunities to optimize departmental processes and improve operational efficiency.\n\nRequired qualifications:\nBachelor's degree required, preferably in a science or engineering-related field.\nMinimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.\nComputer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).\nAbility to communicate effectively at all levels.\nSound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.\nMust be able to identify opportunities for optimization of processes within the department or the plant.\nAbility to work independently or in teams.\n\nPhysical / Safety Requirements:\nDuties may require overtime work, including nights and weekends\nMust be able to gown for Grade C environments\nUse of hands and fingers to manipulate office equipment is required\nPosition requires sitting for long hours, but may involve walking or standing for periods of time.\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\nEmployee Ownership Plan\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":"2026-08-03T17:42:31.523Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"}],"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 Validation Associate III","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\nThe role:\nThis position executes process validation activities that meet worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position interacts with the client and the cross functional client team members to develop process validation strategies and creates process validation protocol and summary documents. This position reports to the Process Validation Sr. Manager.\n\nThe responsibilities:\nSupport and maintain the process validation program.\nDevelop, revise, and maintain process validation procedures, protocols, and summary reports.\nPartner with clients and internal teams to define validation scope, requirements, and objectives.\nDesign, execute, and analyze technical studies using statistical tools to establish and evaluate process parameters.\nPerform risk assessments to support process validation activities.\nPlan, coordinate, and execute process validation activities for new and existing products.\nAnalyze validation data and prepare documentation to support validation conclusions.\nConduct annual reviews and Continued Process Verification (CPV) activities to ensure ongoing process performance.\nLead or support investigations related to validation activities, including Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).\nMonitor regulatory requirements and industry best practices to ensure compliance and continuous improvement.\nCreate and maintain visual management tools and controls for the Process Validation group.\nServe as a Subject Matter Expert (SME) for process validation during regulatory, client, and internal audits.\nDevelop industry expertise and project proficiency while working independently on assigned initiatives.\nIdentify and implement opportunities to optimize departmental processes and improve operational efficiency.\n\nRequired qualifications:\nBachelor's degree required, preferably in a science or engineering-related field.\nMinimum of 5 years of technical experience (validation preferred) in parenteral manufacturing.\nComputer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).\nAbility to communicate effectively at all levels.\nSound industry knowledge, project proficiency, and be able to work independently. May be considered a subject matter expert (SME) in various disciplines.\nMust be able to identify opportunities for optimization of processes within the department or the plant.\nAbility to work independently or in teams.\n\nPhysical / Safety Requirements:\nDuties may require overtime work, including nights and weekends\nMust be able to gown for Grade C environments\nUse of hands and fingers to manipulate office equipment is required\nPosition requires sitting for long hours, but may involve walking or standing for periods of time.\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\nEmployee Ownership Plan\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":"2026-08-03T17:42:31.523Z","dateModified":"2026-08-03T17:42:31.523Z","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":"6ba51bbf4d29af1dc841c437"},"url":"https://jobsearcher.com/jobs/6ba51bbf4d29af1dc841c437"}}