{"schemaVersion":"jobsearcher.job.v1","id":"0a6e48778870ce61c261a42e","url":"https://jobsearcher.com/jobs/0a6e48778870ce61c261a42e","canonicalUrl":"https://jobsearcher.com/jobs/0a6e48778870ce61c261a42e","title":"Process Validation Engineer, Advanced Manufacturing Engineering","description":"City: Noblesville\nCountry/Region: United States\nState: Indiana\nBusiness Area: Production\nDepartment: Production, NV - IE\nEmployment Type: Full-time\nReq ID: 9766\nAmbu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.\n\nThis role will be based out of the Ambu America's Center of Excellence located at the Noblesville, Indiana manufacturing facility. The role has overall responsibility for the Advanced Manufacturing Engineering functions of both the Noblesville, IN and the Juarez, MX manufacturing sites. The expected travel for this role is up to 50%.\n\nObjective:\nThe Process Validation Engineer leads the validation aspects of Automation and Equipment Capital projects, process improvements, supports the development of automated solutions, is responsible of the validation of new equipment installation, ensuring seamless process transfer and readiness to production.\n\nResponsibilities and Essential Functions:\nCompliance and Validation:\nValidation Documents preparation and execution, to ensure all automated systems and/or process improvements are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards, before release to production.\nEvaluation of validation strategy to ensure quick and compliant transfer of processes and equipment to production.\nMaintenance of the Agile documents related to processes and equipment, like SOP, flow charts, electrical drawings, 2D/3D drawings, equipment parameter list (CP), equipment logic program (LCP).\nComplying with FDA QSR, ISO 13485, and relevant product-specific regulations (e.g., IEC 60601, ISO 14971).\nOperational & Regulatory Excellence\n\nAutomation & Smart Manufacturing:\nAssist to the design and implementation of automated manufacturing and assembly systems (e.g., robotics, PLCs, vision systems, motion control) to support precision, repeatability, and compliance.\nAssist to automation and equipment capital projects from concept to installation and validation.\nThe role requires to be “hands on”, on the process and equipment, when needed.\nOperational Excellence:\nChampion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations.\n\nAuthorities:\nAbility to approve validation protocols, test plans, and reports.\nAuthority to sign off on equipment and process validation documentation.\nDetermine corrective and preventive actions (CAPA) related to validation findings.\n\nWork Environment:\nThis is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.\n\nQualifications:\nBachelor’s degree in related field and 3 - 5 years of relevant work experience.\nFive years’ experience working in the medical device field.\nStrong background in medical device process validation, and regulatory compliance.\nAbility to complete complex reports and correspondence.\nMust be able to speak, read, write and understand English.\nBilingual in Spanish is preferred.\n\nAmbu Provided Training within the first six months:\n\nAgile, Change Control System\nMovex, ERP System\nMedius, Procurement System\nValidation Training\nAbout Ambu\nAmbu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.\n\nFor more information, please visit ambu.com or follow us on LinkedIn.\nAbout Ambu\nAmbu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.\nFor more information, please visit ambu.com or follow us on LinkedIn.","company":"Ambu","rawCompany":"ambu","city":"Noblesville","state":"IN","isRemote":false,"isActive":false,"createdAt":"2026-04-14T10:41:33.875Z","occupations":[{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"},{"code":"17-2112.03","title":"Manufacturing Engineers","slug":"manufacturing-engineers"},{"code":"17-2031.00","title":"Bioengineers and Biomedical Engineers","slug":"bioengineers-and-biomedical-engineers"}],"industries":[{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"333248","title":"All Other Industrial Machinery Manufacturing","slug":"all-other-industrial-machinery-manufacturing"},{"code":"334513","title":"Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables","slug":"instruments-and-related-products-manufacturing-for-measuring-displaying-and-controlling-industrial-process-variables"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Process Validation Engineer, Advanced Manufacturing Engineering","description":"City: Noblesville\nCountry/Region: United States\nState: Indiana\nBusiness Area: Production\nDepartment: Production, NV - IE\nEmployment Type: Full-time\nReq ID: 9766\nAmbu provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.\n\nThis role will be based out of the Ambu America's Center of Excellence located at the Noblesville, Indiana manufacturing facility. The role has overall responsibility for the Advanced Manufacturing Engineering functions of both the Noblesville, IN and the Juarez, MX manufacturing sites. The expected travel for this role is up to 50%.\n\nObjective:\nThe Process Validation Engineer leads the validation aspects of Automation and Equipment Capital projects, process improvements, supports the development of automated solutions, is responsible of the validation of new equipment installation, ensuring seamless process transfer and readiness to production.\n\nResponsibilities and Essential Functions:\nCompliance and Validation:\nValidation Documents preparation and execution, to ensure all automated systems and/or process improvements are validated (IQ/OQ/PQ) and fully compliant with 21 CFR Part 820 and other applicable standards, before release to production.\nEvaluation of validation strategy to ensure quick and compliant transfer of processes and equipment to production.\nMaintenance of the Agile documents related to processes and equipment, like SOP, flow charts, electrical drawings, 2D/3D drawings, equipment parameter list (CP), equipment logic program (LCP).\nComplying with FDA QSR, ISO 13485, and relevant product-specific regulations (e.g., IEC 60601, ISO 14971).\nOperational & Regulatory Excellence\n\nAutomation & Smart Manufacturing:\nAssist to the design and implementation of automated manufacturing and assembly systems (e.g., robotics, PLCs, vision systems, motion control) to support precision, repeatability, and compliance.\nAssist to automation and equipment capital projects from concept to installation and validation.\nThe role requires to be “hands on”, on the process and equipment, when needed.\nOperational Excellence:\nChampion Lean, Six Sigma, and Design for Manufacturability (DFM/DFA) principles across internal and outsourced operations.\n\nAuthorities:\nAbility to approve validation protocols, test plans, and reports.\nAuthority to sign off on equipment and process validation documentation.\nDetermine corrective and preventive actions (CAPA) related to validation findings.\n\nWork Environment:\nThis is a manufacturing facility and as a result, employees have the potential to be exposed to noise, chemicals, fumes, airborne particles, machinery, vibration or other workplace hazards controlled within compliance of current safety and health standards.\n\nQualifications:\nBachelor’s degree in related field and 3 - 5 years of relevant work experience.\nFive years’ experience working in the medical device field.\nStrong background in medical device process validation, and regulatory compliance.\nAbility to complete complex reports and correspondence.\nMust be able to speak, read, write and understand English.\nBilingual in Spanish is preferred.\n\nAmbu Provided Training within the first six months:\n\nAgile, Change Control System\nMovex, ERP System\nMedius, Procurement System\nValidation Training\nAbout Ambu\nAmbu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.\n\nFor more information, please visit ambu.com or follow us on LinkedIn.\nAbout Ambu\nAmbu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.\nFor more information, please visit ambu.com or follow us on LinkedIn.","datePosted":"2026-04-14T10:41:33.875Z","dateModified":"2026-04-14T10:41:33.875Z","hiringOrganization":{"@type":"Organization","name":"Ambu","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Noblesville","addressRegion":"IN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"0a6e48778870ce61c261a42e"},"url":"https://jobsearcher.com/jobs/0a6e48778870ce61c261a42e"}}