{"schemaVersion":"jobsearcher.job.v1","id":"b5764321c7d78c6281406693","url":"https://jobsearcher.com/jobs/b5764321c7d78c6281406693","canonicalUrl":"https://jobsearcher.com/jobs/b5764321c7d78c6281406693","title":"Quality Engineer","description":"Salary Range: $100,000.00 To $130,000.00 Annually\n\nPOSITION SUMMARY\nThe cGMP Quality Engineer is accountable for ensuring that radiopharmaceutical manufacturing processes, equipment, and facilities operate in sustained compliance with cGMP, regulatory requirements, and internal quality standards. This role provides quality oversight and governance for process validation, equipment qualification, and manufacturing operations, ensuring that validated and qualified states are properly documented, maintained, and defended.\n\nWorking closely with Manufacturing, MSAT, and Quality Assurance, the Quality Engineer serves as the quality authority embedded in technical operations, enabling compliant execution while maintaining inspection readiness. The role focuses on risk management, deviation control, and lifecycle quality assurance, rather than execution of validation or process design.\n\nKEY RESPONSIBILITIES\n\nLead and own deviation investigations, root cause analysis, and the development and effectiveness of corrective and preventive actions (CAPA).\n\nProvide quality oversight for process validation, equipment qualification, aseptic processing, and cleanroom operations, ensuring adherence to approved protocols and regulatory expectations.\n\nSupport site readiness activities including facility and cleanroom qualification, process startup, and introduction of new or modified manufacturing processes from a quality perspective.\n\nReview and approve GMP documentation, including protocols, reports, procedures, and technical change records, ensuring data integrity and compliance.\n\nSupport internal, client, and regulatory audits and contribute quality input to regulatory submissions.\n\nDrive continuous improvement initiatives focused on compliance robustness, inspection readiness, and right-first-time manufacturing.\n\nStrong attention to detail, problem-solving ability, and knowledge of pharmaceutical quality systems are essential to ensure safe, compliant, and reliable production.\n\nPRIMARY RESPONSIBILITIES\n\nDevelop, implement, and maintain quality procedures, processes, and documentation in compliance with relevant industry regulations and standards (e.g., FDA, ISO, GMP, USP).\n\nConduct internal audits and support external audits/inspections by clients and regulatory agencies.\n\nParticipate in the management of the QMS, including document control, training, and record-keeping.\n\nReview and approve project documents, protocols, and reports related to process validation, equipment qualification, and test methodologies.\n\nSupport validation activities for manufacturing processes, equipment, utilities, and cleanrooms.\n\nCollaborate with Manufacturing, MSAT, and QA teams to maintain quality control measures on the production floor.\n\nInvestigate and document quality issues, deviations, and non-conformances; support root cause analysis and corrective/preventive actions (CAPA).\n\nLead investigations into quality issues, customer complaints, and non-conformities to identify root causes using systematic problem-solving methodologies.\n\nTrack and trend quality data to identify recurring issues and opportunities for improvement.\n\nReview and approve incoming materials, supplier documentation and change controls as appropriate.\n\nAuthor, review, and approve regulated documents, including standard operating procedures (SOPs), test protocols, and reports.\n\nAssist in supplier qualifications and audits to ensure compliance with quality standards.\n\nProvide training and guidance to staff on quality assurance principles, and procedures.\n\nMaintain accurate, compliant records of quality processes, procedures, and activities.\n\nEnsure compliance with applicable quality and regulatory requirements (21 CFR 210/211/212, USP , EU GMP Annex 1 as applicable, and NRC, DOT Class 7).\n\nServe as SME during inspections and regulatory interactions.\n\nSelect, commission, and validate radiosynthesis platforms, hot cells, and automation systems, support training on new technologies.\n\nOversee transfer documentation (URS, pRA, PQ) and deploy MES/eBR, LIMS, and quality-by-design solutions for data integrity and review-by-exception.\n\nImplement digital analytics to increase transparency and manufacturing efficiency.\n\nPartner with Supply Chain to secure consumables, spare parts, and critical materials.\n\nApply ICH Q9 risk management to proactively address compliance and operational challenges.\n\nDrive continuous improvement to stabilize processes, enhance yield, and reduce cost without compromising safety or quality.\n\nEnsure radiation safety and ALARA compliance in partnership with RSO and EHS.\n\nQUALIFICATIONS & REQUIREMENTS\n\nBachelor’s degree in engineering (e.g., Chemical, Biomedical, Mechanical, Electrical), Chemistry, Life Sciences, or equivalent, or related field. A master’s degree or relevant certification (e.g., ASQ Certified Quality Engineer - CQE) is a plus.\n\nA minimum of 6 years of experience in a Quality Engineering or Quality Assurance role within a regulated industry, preferably medical devices or pharmaceuticals. Experience with radiopharmaceuticals is highly desirable.\n\nTECHNICAL SKILLS\n\nStrong knowledge of cGMP regulations and pharmaceutical quality systems (e.g., FDA 21 CFR Parts 210/211, 820, Part 11 and Annex 1).\n\nFamiliarity with GxP, compliance and phase-appropriate validation requirements.\n\nExperience with risk management tools and methodologies (e.g., FMEA, risk assessments, hazard analysis).\n\nProficiency in root cause analysis, statistical analysis, and other structured problem-solving methods.\n\nKnowledge of validation and qualification techniques for processes, equipment, utilities, software, and cleanrooms.\n\nFamiliarity with radiation safety principles (e.g., ALARA) is preferred.\n\nSOFT SKILLS\n\nExcellent written and verbal communication skills.\n\nStrong analytical, problem-solving, and critical thinking abilities.\n\nHighly organized with strong attention to detail.\n\nAbility to work independently and collaboratively in a cross-functional team environment.\n\nStrong project management skills, with the ability to prioritize and manage multiple tasks.\n\nBenefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.\n\nThis job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.\n\nNucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.\n\n#J-18808-Ljbffr","company":"Evolving Solution Services","rawCompany":"evolving solution services","city":"Rochester","state":"MN","isRemote":false,"isActive":false,"createdAt":"2026-06-30T03:14:57.476Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"334510","title":"Electromedical and Electrotherapeutic Apparatus Manufacturing","slug":"electromedical-and-electrotherapeutic-apparatus-manufacturing"},{"code":"325414","title":"Biological Product (except Diagnostic) Manufacturing","slug":"biological-product-except-diagnostic-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer","description":"Salary Range: $100,000.00 To $130,000.00 Annually\n\nPOSITION SUMMARY\nThe cGMP Quality Engineer is accountable for ensuring that radiopharmaceutical manufacturing processes, equipment, and facilities operate in sustained compliance with cGMP, regulatory requirements, and internal quality standards. This role provides quality oversight and governance for process validation, equipment qualification, and manufacturing operations, ensuring that validated and qualified states are properly documented, maintained, and defended.\n\nWorking closely with Manufacturing, MSAT, and Quality Assurance, the Quality Engineer serves as the quality authority embedded in technical operations, enabling compliant execution while maintaining inspection readiness. The role focuses on risk management, deviation control, and lifecycle quality assurance, rather than execution of validation or process design.\n\nKEY RESPONSIBILITIES\n\nLead and own deviation investigations, root cause analysis, and the development and effectiveness of corrective and preventive actions (CAPA).\n\nProvide quality oversight for process validation, equipment qualification, aseptic processing, and cleanroom operations, ensuring adherence to approved protocols and regulatory expectations.\n\nSupport site readiness activities including facility and cleanroom qualification, process startup, and introduction of new or modified manufacturing processes from a quality perspective.\n\nReview and approve GMP documentation, including protocols, reports, procedures, and technical change records, ensuring data integrity and compliance.\n\nSupport internal, client, and regulatory audits and contribute quality input to regulatory submissions.\n\nDrive continuous improvement initiatives focused on compliance robustness, inspection readiness, and right-first-time manufacturing.\n\nStrong attention to detail, problem-solving ability, and knowledge of pharmaceutical quality systems are essential to ensure safe, compliant, and reliable production.\n\nPRIMARY RESPONSIBILITIES\n\nDevelop, implement, and maintain quality procedures, processes, and documentation in compliance with relevant industry regulations and standards (e.g., FDA, ISO, GMP, USP).\n\nConduct internal audits and support external audits/inspections by clients and regulatory agencies.\n\nParticipate in the management of the QMS, including document control, training, and record-keeping.\n\nReview and approve project documents, protocols, and reports related to process validation, equipment qualification, and test methodologies.\n\nSupport validation activities for manufacturing processes, equipment, utilities, and cleanrooms.\n\nCollaborate with Manufacturing, MSAT, and QA teams to maintain quality control measures on the production floor.\n\nInvestigate and document quality issues, deviations, and non-conformances; support root cause analysis and corrective/preventive actions (CAPA).\n\nLead investigations into quality issues, customer complaints, and non-conformities to identify root causes using systematic problem-solving methodologies.\n\nTrack and trend quality data to identify recurring issues and opportunities for improvement.\n\nReview and approve incoming materials, supplier documentation and change controls as appropriate.\n\nAuthor, review, and approve regulated documents, including standard operating procedures (SOPs), test protocols, and reports.\n\nAssist in supplier qualifications and audits to ensure compliance with quality standards.\n\nProvide training and guidance to staff on quality assurance principles, and procedures.\n\nMaintain accurate, compliant records of quality processes, procedures, and activities.\n\nEnsure compliance with applicable quality and regulatory requirements (21 CFR 210/211/212, USP , EU GMP Annex 1 as applicable, and NRC, DOT Class 7).\n\nServe as SME during inspections and regulatory interactions.\n\nSelect, commission, and validate radiosynthesis platforms, hot cells, and automation systems, support training on new technologies.\n\nOversee transfer documentation (URS, pRA, PQ) and deploy MES/eBR, LIMS, and quality-by-design solutions for data integrity and review-by-exception.\n\nImplement digital analytics to increase transparency and manufacturing efficiency.\n\nPartner with Supply Chain to secure consumables, spare parts, and critical materials.\n\nApply ICH Q9 risk management to proactively address compliance and operational challenges.\n\nDrive continuous improvement to stabilize processes, enhance yield, and reduce cost without compromising safety or quality.\n\nEnsure radiation safety and ALARA compliance in partnership with RSO and EHS.\n\nQUALIFICATIONS & REQUIREMENTS\n\nBachelor’s degree in engineering (e.g., Chemical, Biomedical, Mechanical, Electrical), Chemistry, Life Sciences, or equivalent, or related field. A master’s degree or relevant certification (e.g., ASQ Certified Quality Engineer - CQE) is a plus.\n\nA minimum of 6 years of experience in a Quality Engineering or Quality Assurance role within a regulated industry, preferably medical devices or pharmaceuticals. Experience with radiopharmaceuticals is highly desirable.\n\nTECHNICAL SKILLS\n\nStrong knowledge of cGMP regulations and pharmaceutical quality systems (e.g., FDA 21 CFR Parts 210/211, 820, Part 11 and Annex 1).\n\nFamiliarity with GxP, compliance and phase-appropriate validation requirements.\n\nExperience with risk management tools and methodologies (e.g., FMEA, risk assessments, hazard analysis).\n\nProficiency in root cause analysis, statistical analysis, and other structured problem-solving methods.\n\nKnowledge of validation and qualification techniques for processes, equipment, utilities, software, and cleanrooms.\n\nFamiliarity with radiation safety principles (e.g., ALARA) is preferred.\n\nSOFT SKILLS\n\nExcellent written and verbal communication skills.\n\nStrong analytical, problem-solving, and critical thinking abilities.\n\nHighly organized with strong attention to detail.\n\nAbility to work independently and collaboratively in a cross-functional team environment.\n\nStrong project management skills, with the ability to prioritize and manage multiple tasks.\n\nBenefit packages for this role include medical, dental, and vision insurance, as well as a Health Savings Account or Flexible Spending Account options (depending on the plan chosen), and 401k retirement account access with employer matching. Team members in this role are also entitled to paid sick leave and/or other paid time off in compliance with applicable law. Relocation is available to qualified team members.\n\nThis job description is a summary of the typical functions of the position, not necessarily an exhaustive or comprehensive list of all possible position responsibilities, tasks, and duties. The company reserves the right to assign or reassign duties and responsibilities to this job at any time. This job does not constitute a written or implied contract of employment; employment remains “at-will”.\n\nNucleus RadioPharma is an equal opportunity employer and believes everyone deserves respect, dignity, and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.\n\n#J-18808-Ljbffr","datePosted":"2026-06-30T03:14:57.476Z","dateModified":"2026-06-30T03:14:57.476Z","hiringOrganization":{"@type":"Organization","name":"Evolving Solution Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Rochester","addressRegion":"MN","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"b5764321c7d78c6281406693"},"url":"https://jobsearcher.com/jobs/b5764321c7d78c6281406693"}}