{"schemaVersion":"jobsearcher.job.v1","id":"8e47a3c8a001e36769ee4e93","url":"https://jobsearcher.com/jobs/8e47a3c8a001e36769ee4e93","canonicalUrl":"https://jobsearcher.com/jobs/8e47a3c8a001e36769ee4e93","title":"Sr. Process Validation 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.\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.\nWhy join Team Simtra? Make 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.\nSenior Process Validation Engineer The Senior Process Validation Engineer is a key member of the Technical Services organization, responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment. This role focuses on process validation strategy, execution, lifecycle management, and maintaining the validated state to ensure compliant, robust, and inspection‑ready operations.\nThe Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement a risk‑based approach that supports safe, reliable, and scalable sterile drug product manufacturing. This position is full‑time and based onsite at the Simtra Bloomington facility.\nResponsibilities Provide technical and strategic leadership for process validation of new and existing sterile injectable manufacturing processes, including formulation, compounding, filtration, aseptic filling, lyophilization, and terminal sterilization, as applicable\nOwn and drive lifecycle process validation strategy, ensuring risk‑based, scientifically justified approaches aligned with FDA/EMA guidance, ICH expectations, and internal quality standards\nLead the development, review, and approval of key validation deliverables, including Process Validation Master Plans, risk assessments, protocols, control strategy elements, and final validation summary reports\nSet validation direction and standards for parameters, sampling strategies, acceptance criteria, and statistical approaches; ensure consistent application across products, programs, and manufacturing areas\nServe as the primary validation interface with Manufacturing, Quality, Engineering, and external clients to ensure end‑to‑end process readiness for PPQ and commercial manufacturing\nLead process validation planning and execution for technology transfers, including assessment of development history, identification of validation gaps, definition of validation scope, and readiness for PPQ execution\nProvide senior oversight and technical guidance for equipment, facility, and utility qualification activities, ensuring robust alignment with process validation requirements\nProvide expert validation impact assessments for changes related to process, equipment, raw materials, analytical methods, and facilities, supporting change control and regulatory commitments\nEstablish and oversee continued process verification programs\nAct as on‑floor validation lead during PPQ execution, process confirmation runs, technology transfer campaigns, and high‑risk or high‑visibility manufacturing operations\nEnsure validation documentation is inspection‑ready, supporting internal audits, client audits, and global regulatory inspections\nServe as a SME during regulatory inspections and client audits; lead inspection preparation, participate in interviews, and support responses to inspection observations\nContinuously improve validation practices, incorporating lessons learned, regulatory trends, and industry best practices to enhance efficiency, compliance, and product quality\nRequired qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical discipline\n5–8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environment\nStrong understanding of sterile injectable manufacturing processes and aseptic processing principles\nSolid working knowledge of cGMP requirements and validation lifecycle concepts\nDemonstrated experience authoring and executing process validation protocols and reports\nPreferred qualifications Experience working in a CDMO environment and sterile injectable drug product manufacturing\nFamiliarity with equipment and facility qualification and CSV validation\nExperience supporting regulatory inspections and client audits as a validation SME\nKnowledge of continued process verification, process capability analysis, and lifecycle management\nExperience working with electronic validation systems, MES, or electronic batch records\nPhysical / safety requirements Occasional overtime may be required, including evenings or weekends to support validation execution or manufacturing schedules\nPosition requires extended periods of sitting with routine walking and standing in manufacturing areas\nMust be able to qualify for classified manufacturing area gowning as applicable\nMust be able to wear required personal protective equipment (PPE)\nIn return, you'll be eligible for Day One Benefits Medical & Dental Coverage\nFlexible Spending Accounts\nLife and AD&D Insurance\nSupplemental Life Insurance Spouse Life Insurance\nChild Life Insurance\n\n401(k) Retirement Savings Plan with Company Match\nTime Off Program Paid Holidays\nPaid Time Off\nPaid Parental Leave and more\n\nAdoption Reimbursement Program\nEducation Assistance Program\nEmployee Assistance Program\nCommunity and Volunteer Service Program\nAdditional Benefits Short and Long‑Term Disability Insurance\n\nVoluntary Insurance Benefits Vision Coverage\nAccident\nCritical Illness\nHospital Indemnity Insurance\nIdentity Theft Protection\nLegal and more\n\nOnsite Campus Amenities Workout Facility\nCafeteria\nCredit Union\n\n[1] Current benefit offerings are in effect through 12/31/26\nDisclaimer This 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.\nEqual Employment Opportunity Simtra 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.\nData Privacy To 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":"Simtra Us","rawCompany":"simtra us","city":"Bloomington","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-07-16T03:29:23.214Z","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":"Sr. Process Validation 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.\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.\nWhy join Team Simtra? Make 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.\nSenior Process Validation Engineer The Senior Process Validation Engineer is a key member of the Technical Services organization, responsible for leading and supporting validation activities for sterile injectable manufacturing processes within a regulated pharmaceutical CDMO environment. This role focuses on process validation strategy, execution, lifecycle management, and maintaining the validated state to ensure compliant, robust, and inspection‑ready operations.\nThe Senior Process Validation Engineer partners closely with Manufacturing, Quality, Validation, Engineering, Tech Transfer, Supply Chain, and Regulatory teams to implement a risk‑based approach that supports safe, reliable, and scalable sterile drug product manufacturing. This position is full‑time and based onsite at the Simtra Bloomington facility.\nResponsibilities Provide technical and strategic leadership for process validation of new and existing sterile injectable manufacturing processes, including formulation, compounding, filtration, aseptic filling, lyophilization, and terminal sterilization, as applicable\nOwn and drive lifecycle process validation strategy, ensuring risk‑based, scientifically justified approaches aligned with FDA/EMA guidance, ICH expectations, and internal quality standards\nLead the development, review, and approval of key validation deliverables, including Process Validation Master Plans, risk assessments, protocols, control strategy elements, and final validation summary reports\nSet validation direction and standards for parameters, sampling strategies, acceptance criteria, and statistical approaches; ensure consistent application across products, programs, and manufacturing areas\nServe as the primary validation interface with Manufacturing, Quality, Engineering, and external clients to ensure end‑to‑end process readiness for PPQ and commercial manufacturing\nLead process validation planning and execution for technology transfers, including assessment of development history, identification of validation gaps, definition of validation scope, and readiness for PPQ execution\nProvide senior oversight and technical guidance for equipment, facility, and utility qualification activities, ensuring robust alignment with process validation requirements\nProvide expert validation impact assessments for changes related to process, equipment, raw materials, analytical methods, and facilities, supporting change control and regulatory commitments\nEstablish and oversee continued process verification programs\nAct as on‑floor validation lead during PPQ execution, process confirmation runs, technology transfer campaigns, and high‑risk or high‑visibility manufacturing operations\nEnsure validation documentation is inspection‑ready, supporting internal audits, client audits, and global regulatory inspections\nServe as a SME during regulatory inspections and client audits; lead inspection preparation, participate in interviews, and support responses to inspection observations\nContinuously improve validation practices, incorporating lessons learned, regulatory trends, and industry best practices to enhance efficiency, compliance, and product quality\nRequired qualifications Bachelor's degree in Engineering, Life Sciences, or a related technical discipline\n5–8+ years of experience in process validation, CQV, MS&T, or manufacturing support within a regulated pharmaceutical environment\nStrong understanding of sterile injectable manufacturing processes and aseptic processing principles\nSolid working knowledge of cGMP requirements and validation lifecycle concepts\nDemonstrated experience authoring and executing process validation protocols and reports\nPreferred qualifications Experience working in a CDMO environment and sterile injectable drug product manufacturing\nFamiliarity with equipment and facility qualification and CSV validation\nExperience supporting regulatory inspections and client audits as a validation SME\nKnowledge of continued process verification, process capability analysis, and lifecycle management\nExperience working with electronic validation systems, MES, or electronic batch records\nPhysical / safety requirements Occasional overtime may be required, including evenings or weekends to support validation execution or manufacturing schedules\nPosition requires extended periods of sitting with routine walking and standing in manufacturing areas\nMust be able to qualify for classified manufacturing area gowning as applicable\nMust be able to wear required personal protective equipment (PPE)\nIn return, you'll be eligible for Day One Benefits Medical & Dental Coverage\nFlexible Spending Accounts\nLife and AD&D Insurance\nSupplemental Life Insurance Spouse Life Insurance\nChild Life Insurance\n\n401(k) Retirement Savings Plan with Company Match\nTime Off Program Paid Holidays\nPaid Time Off\nPaid Parental Leave and more\n\nAdoption Reimbursement Program\nEducation Assistance Program\nEmployee Assistance Program\nCommunity and Volunteer Service Program\nAdditional Benefits Short and Long‑Term Disability Insurance\n\nVoluntary Insurance Benefits Vision Coverage\nAccident\nCritical Illness\nHospital Indemnity Insurance\nIdentity Theft Protection\nLegal and more\n\nOnsite Campus Amenities Workout Facility\nCafeteria\nCredit Union\n\n[1] Current benefit offerings are in effect through 12/31/26\nDisclaimer This 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.\nEqual Employment Opportunity Simtra 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.\nData Privacy To 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":"2026-07-16T03:29:23.214Z","dateModified":"2026-07-16T03:29:23.214Z","hiringOrganization":{"@type":"Organization","name":"Simtra Us","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Bloomington","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"8e47a3c8a001e36769ee4e93"},"url":"https://jobsearcher.com/jobs/8e47a3c8a001e36769ee4e93"}}