{"schemaVersion":"jobsearcher.job.v1","id":"c7ffd4e2e9b9ca3739538f18","url":"https://jobsearcher.com/jobs/c7ffd4e2e9b9ca3739538f18","canonicalUrl":"https://jobsearcher.com/jobs/c7ffd4e2e9b9ca3739538f18","title":"Associate Director, Reliability Engineering","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.\n\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.\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?\nBecause we:\n\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:\nThe Associate Director of Reliability Engineering is responsible for developing, leading, and continuously improving the site reliability program to maximize equipment uptime, shutdown RTS performance, asset performance, product quality, safety, and regulatory compliance within a pharmaceutical manufacturing environment. This role provides strategic leadership for reliability-centered maintenance (RCM), asset lifecycle management, predictive and preventive maintenance programs, and continuous improvement initiatives across manufacturing, utilities, facilities, laboratories, and packaging operations.\n\nThe Associate Director partners closely with Engineering, Manufacturing, Quality, Validation, Facilities, Supply Chain, and EHS teams to ensure reliable and compliant operation of GMP-regulated systems while supporting business objectives, production targets, and capital investment strategies.\n\nResponsibilities:\nReliability Strategy & Leadership\n\nDevelop and execute the site's Reliability Engineering strategy aligned with business and operational goals.\n\nImprove and optimize manufacturing building shutdown program and vertical RTS (return to service) performance.\n\nLead reliability improvement initiatives for manufacturing equipment, process systems, utilities, and critical facilities.\n\nEstablish reliability standards, policies, procedures, and best practices across the organization.\n\nLead and communication reliability metrics data to site leadership.\n\nServe as the subject matter expert for asset reliability and maintenance excellence.\n\nAsset Reliability & Performance Management\n\nDevelop and manage Reliability-Centered Maintenance (RCM) programs.\n\nAnalyze equipment performance, failure trends, and maintenance effectiveness to improve reliability.\n\nConduct root cause analysis (RCA), failure mode and effects analysis (FMEA), and risk assessments.\n\nIdentify and implement solutions to reduce downtime and improve Overall Equipment Effectiveness (OEE).\n\nEstablish asset criticality models and reliability KPIs.\n\nMaintenance Excellence\n\nPartner with Maintenance and Operations teams to optimize preventive and predictive maintenance programs.\n\nDrive implementation and utilization of condition-based monitoring technologies, including:\n\no Vibration analysis\n\no Infrared thermography\n\no Oil analysis\n\no Ultrasound monitoring\n\no Motor circuit analysis\n\nSupport maintenance planning, scheduling, and work management processes within CMMS platforms.\n\nMonitor maintenance performance metrics and identify continuous improvement opportunities.\n\nPharmaceutical Compliance & Quality\n\nEnsure reliability programs comply with cGMP, FDA, EMA, and applicable regulatory requirements.\n\nSupport regulatory inspections, audits, and quality investigations.\n\nCollaborate with Quality Assurance and Validation teams to maintain validated states of equipment and systems.\n\nParticipate in deviation investigations, CAPA development, and change control processes.\n\nEnsure data integrity, documentation accuracy, and adherence to quality standards.\n\nUtilities, Facilities & Critical Systems\n\nProvide reliability oversight for critical GMP systems, including:\n\no HVAC\n\no Water for Injection (WFI)\n\no Clean Steam\n\no Compressed Air\n\no Building Management Systems (BMS)\n\nSupport risk mitigation strategies for critical utility and facility assets.\n\nLead initiatives to improve system availability and energy efficiency.\n\nCapital Projects & Asset Lifecycle Management\n\nSupport design reviews and reliability requirements for new capital projects.\n\nEnsure maintainability and reliability principles are incorporated into equipment design and procurement.\n\nDevelop asset replacement and lifecycle management strategies.\n\nParticipate in FAT, SAT, commissioning, qualification, and startup activities.\n\nData Analytics & Continuous Improvement\n\nUtilize reliability and maintenance data to drive decision-making.\n\nDevelop dashboards and reports to monitor reliability performance.\n\nLead Lean, Six Sigma, and operational excellence initiatives.\n\nBenchmark reliability performance against industry best practices.\n\nDrive digital transformation initiatives related to smart maintenance and Industry 4.0 technologies.\n\nRequired qualifications\nEducation\n\nBachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related discipline) required.\n\nMaster's degree in Engineering, Business Administration, or related field preferred.\n\nExperience\n\n10+ years of engineering, maintenance, or reliability experience within the pharmaceutical, biotechnology, medical device, or highly regulated manufacturing industries.\n\n5+ years of leadership experience managing technical teams.\n\nDemonstrated success implementing reliability and maintenance excellence programs in GMP-regulated environments.\n\nExperience supporting FDA, EMA, and regulatory inspections.\n\nTechnical Knowledge\n\nReliability-Centered Maintenance (RCM)\n\nRoot Cause Analysis (RCA)\n\nFMEA and Risk-Based Maintenance\n\nCMMS systems (Maximo, D365, Blue Mountain, or similar)\n\nPredictive Maintenance technologies\n\nAsset Lifecycle Management\n\nOEE and Reliability Metrics\n\nGMP manufacturing operations\n\nValidation and Qualification processes\n\nPharmaceutical utility systems\n\nPreferred qualifications\n\nCertified Reliability Engineer (CRE)\n\nCertified Maintenance & Reliability Professional (CMRP)\n\nLean Six Sigma Green Belt or Black Belt\n\nProject Management Professional (PMP)\n\nPhysical / safety requirements\n\nAbility to utilize required personal protective equipment (PPE)\n\nDexterity and physical condition to perform some level of repetitive motion tasks\n\nAbility to stand or sit for extended periods of time\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":"Simtra Us","rawCompany":"simtra us","city":"Bloomington","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-08-06T03:13:50.050Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"11-9199.01","title":"Regulatory Affairs Managers","slug":"regulatory-affairs-managers"},{"code":"11-3051.00","title":"Industrial Production Managers","slug":"industrial-production-managers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Associate Director, Reliability Engineering","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.\n\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.\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?\nBecause we:\n\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:\nThe Associate Director of Reliability Engineering is responsible for developing, leading, and continuously improving the site reliability program to maximize equipment uptime, shutdown RTS performance, asset performance, product quality, safety, and regulatory compliance within a pharmaceutical manufacturing environment. This role provides strategic leadership for reliability-centered maintenance (RCM), asset lifecycle management, predictive and preventive maintenance programs, and continuous improvement initiatives across manufacturing, utilities, facilities, laboratories, and packaging operations.\n\nThe Associate Director partners closely with Engineering, Manufacturing, Quality, Validation, Facilities, Supply Chain, and EHS teams to ensure reliable and compliant operation of GMP-regulated systems while supporting business objectives, production targets, and capital investment strategies.\n\nResponsibilities:\nReliability Strategy & Leadership\n\nDevelop and execute the site's Reliability Engineering strategy aligned with business and operational goals.\n\nImprove and optimize manufacturing building shutdown program and vertical RTS (return to service) performance.\n\nLead reliability improvement initiatives for manufacturing equipment, process systems, utilities, and critical facilities.\n\nEstablish reliability standards, policies, procedures, and best practices across the organization.\n\nLead and communication reliability metrics data to site leadership.\n\nServe as the subject matter expert for asset reliability and maintenance excellence.\n\nAsset Reliability & Performance Management\n\nDevelop and manage Reliability-Centered Maintenance (RCM) programs.\n\nAnalyze equipment performance, failure trends, and maintenance effectiveness to improve reliability.\n\nConduct root cause analysis (RCA), failure mode and effects analysis (FMEA), and risk assessments.\n\nIdentify and implement solutions to reduce downtime and improve Overall Equipment Effectiveness (OEE).\n\nEstablish asset criticality models and reliability KPIs.\n\nMaintenance Excellence\n\nPartner with Maintenance and Operations teams to optimize preventive and predictive maintenance programs.\n\nDrive implementation and utilization of condition-based monitoring technologies, including:\n\no Vibration analysis\n\no Infrared thermography\n\no Oil analysis\n\no Ultrasound monitoring\n\no Motor circuit analysis\n\nSupport maintenance planning, scheduling, and work management processes within CMMS platforms.\n\nMonitor maintenance performance metrics and identify continuous improvement opportunities.\n\nPharmaceutical Compliance & Quality\n\nEnsure reliability programs comply with cGMP, FDA, EMA, and applicable regulatory requirements.\n\nSupport regulatory inspections, audits, and quality investigations.\n\nCollaborate with Quality Assurance and Validation teams to maintain validated states of equipment and systems.\n\nParticipate in deviation investigations, CAPA development, and change control processes.\n\nEnsure data integrity, documentation accuracy, and adherence to quality standards.\n\nUtilities, Facilities & Critical Systems\n\nProvide reliability oversight for critical GMP systems, including:\n\no HVAC\n\no Water for Injection (WFI)\n\no Clean Steam\n\no Compressed Air\n\no Building Management Systems (BMS)\n\nSupport risk mitigation strategies for critical utility and facility assets.\n\nLead initiatives to improve system availability and energy efficiency.\n\nCapital Projects & Asset Lifecycle Management\n\nSupport design reviews and reliability requirements for new capital projects.\n\nEnsure maintainability and reliability principles are incorporated into equipment design and procurement.\n\nDevelop asset replacement and lifecycle management strategies.\n\nParticipate in FAT, SAT, commissioning, qualification, and startup activities.\n\nData Analytics & Continuous Improvement\n\nUtilize reliability and maintenance data to drive decision-making.\n\nDevelop dashboards and reports to monitor reliability performance.\n\nLead Lean, Six Sigma, and operational excellence initiatives.\n\nBenchmark reliability performance against industry best practices.\n\nDrive digital transformation initiatives related to smart maintenance and Industry 4.0 technologies.\n\nRequired qualifications\nEducation\n\nBachelor's degree in Engineering (Mechanical, Chemical, Electrical, Industrial, or related discipline) required.\n\nMaster's degree in Engineering, Business Administration, or related field preferred.\n\nExperience\n\n10+ years of engineering, maintenance, or reliability experience within the pharmaceutical, biotechnology, medical device, or highly regulated manufacturing industries.\n\n5+ years of leadership experience managing technical teams.\n\nDemonstrated success implementing reliability and maintenance excellence programs in GMP-regulated environments.\n\nExperience supporting FDA, EMA, and regulatory inspections.\n\nTechnical Knowledge\n\nReliability-Centered Maintenance (RCM)\n\nRoot Cause Analysis (RCA)\n\nFMEA and Risk-Based Maintenance\n\nCMMS systems (Maximo, D365, Blue Mountain, or similar)\n\nPredictive Maintenance technologies\n\nAsset Lifecycle Management\n\nOEE and Reliability Metrics\n\nGMP manufacturing operations\n\nValidation and Qualification processes\n\nPharmaceutical utility systems\n\nPreferred qualifications\n\nCertified Reliability Engineer (CRE)\n\nCertified Maintenance & Reliability Professional (CMRP)\n\nLean Six Sigma Green Belt or Black Belt\n\nProject Management Professional (PMP)\n\nPhysical / safety requirements\n\nAbility to utilize required personal protective equipment (PPE)\n\nDexterity and physical condition to perform some level of repetitive motion tasks\n\nAbility to stand or sit for extended periods of time\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":"2026-08-06T03:13:50.050Z","dateModified":"2026-08-06T03:13:50.050Z","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":"c7ffd4e2e9b9ca3739538f18"},"url":"https://jobsearcher.com/jobs/c7ffd4e2e9b9ca3739538f18"}}