{"schemaVersion":"jobsearcher.job.v1","id":"f9d72739a96b9d44a52de0a2","url":"https://jobsearcher.com/jobs/f9d72739a96b9d44a52de0a2","canonicalUrl":"https://jobsearcher.com/jobs/f9d72739a96b9d44a52de0a2","title":"Quality Engineer -Sustaining Engineering (SE)","description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\n\nWe are PCI.\n\nOur investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.\n\nSummary of Objective:\nThe Quality Engineer (QE) is a key, customer-facing role that will be responsible for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI’s Advanced Drug Delivery business. The QE will partner with other internal team members to ensure a successful design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership.\n\nAs the new product is fully scaled into commercial operations, the QE will be responsible or support all phases process qualification, ensuring the product is produced according to the established control plan, design and product specifications, and driving continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality.\n\nThe QVE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed.\n\nEssential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.\nTechnical (Product and Process)\nDrive and support new customer programs throughout the development lifecycle and deliver on the ‘One PCI’ customer experience and program management\nInteract with clients on an as-needed basis to support project milestones, scope changes and business development opportunities.\nDevelop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams.\nPrepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plan for new customer/product/system project launch and maintains existing validated processes and coordinating internal and customer approvals, as needed.\nEnsures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.\nDevelopment of sampling plans for OQ/PQ activities (includes Serialization activities).\nTrend manufacturing data and contract service providers results for ongoing process verification.\nReviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.\nReview and/or approve User Requirement Specifications, Functional Specifications, and Engineering Study Protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment.\nHarmonization/streamlining of validation activities\nAssistance with development of Master Batch Records, work instructions and associated manufacturing and packaging documentation.\nDrive root cause analysis of deviations.\nSupport project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes.\nDevelop validation work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget.\nInterpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards.\nEffectively communicates project goals and progress to Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.\nCoordinate validation efforts with mechanics, operators, and engineering\nAttends conference calls and meetings\nLeadership\nCollaborate with the engineering, commercial operations, procurement and ancillary groups and wider development, manufacturing, and procurement teams for high priority product-program initiatives.\nAttention to detail and self-motivation to deliver work to the highest standards.\nMulti-tasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently.\nTimely problem-solving using data driven tools and methods.\nPresentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.\nOther - General\n\nAttendance to work is an essential function of this position.\nPerforms other duties as assigned by Manager/Supervisor within device assembly and packaging operations. May assist in the areas of NPI as needed.\nSupport the recruitment, management, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.\nKnowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.\n\nQualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nRequired:\nCollege or Trade Degree required (engineering degree or related scientific degree preferred). Must have a minimum of at least three years of experience in an FDA regulated industry with strong preference to medical device or combination products.\nDemonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.\nAdvanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.\nFull Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.\nAnalytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.\nPreferred:\nLean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.\nPossesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.\nPrior experience in technical writing and utilizing root cause analysis tools is required.\nCritical thinking skills along with a strong collaborative approach is required.\nTechnical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.\n*The hiring rate for this position is $97.280.00-$115,520 plus eligibility for an 5% MBP. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.\n#LI-SW1\nJoin us and be part of building the bridge between life changing therapies and patients.\nLet’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.\nAt PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.","company":"Pcipharmaservices","rawCompany":"pcipharmaservices","city":"Springfield","state":"IL","isRemote":false,"isActive":false,"createdAt":"2026-04-26T12:27:35.586Z","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":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Quality Engineer -Sustaining Engineering (SE)","description":"Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.\n\nWe are PCI.\n\nOur investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.\n\nSummary of Objective:\nThe Quality Engineer (QE) is a key, customer-facing role that will be responsible for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI’s Advanced Drug Delivery business. The QE will partner with other internal team members to ensure a successful design/tech transfer with NPI by directly supporting or driving validation processes with appropriate risk management leadership.\n\nAs the new product is fully scaled into commercial operations, the QE will be responsible or support all phases process qualification, ensuring the product is produced according to the established control plan, design and product specifications, and driving continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality.\n\nThe QVE will interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed.\n\nEssential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.\nTechnical (Product and Process)\nDrive and support new customer programs throughout the development lifecycle and deliver on the ‘One PCI’ customer experience and program management\nInteract with clients on an as-needed basis to support project milestones, scope changes and business development opportunities.\nDevelop and implement product and process workflows to ensure best engineering practices within the quality and engineering teams.\nPrepares and executes validation protocols (IOQ, OQ/PQ) and validation standards, validation statements, reports, summaries, and master validation plan for new customer/product/system project launch and maintains existing validated processes and coordinating internal and customer approvals, as needed.\nEnsures validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals as required.\nDevelopment of sampling plans for OQ/PQ activities (includes Serialization activities).\nTrend manufacturing data and contract service providers results for ongoing process verification.\nReviews and interprets standards, procedures, and specifications for dissemination relative to validation protocols.\nReview and/or approve User Requirement Specifications, Functional Specifications, and Engineering Study Protocols Review and possibly assist in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify equipment.\nHarmonization/streamlining of validation activities\nAssistance with development of Master Batch Records, work instructions and associated manufacturing and packaging documentation.\nDrive root cause analysis of deviations.\nSupport project teams through the selection of correct design / manufacturing concepts and fundamental technology to ensure successful project outcomes.\nDevelop validation work standards and packages as part of project acquisition process and following subsequent project delivery stages, to successfully deliver projects within scope, with quality, and within allocated timeframes and budget.\nInterpret product requirements and design and develop concepts, components, assemblies, and products in compliance with applicable quality system procedures, industry, and business standards.\nEffectively communicates project goals and progress to Supervisor / Manager. Investigates validation deviations, documenting in formal reports, and assuring resolution of corrective action to complete the project.\nCoordinate validation efforts with mechanics, operators, and engineering\nAttends conference calls and meetings\nLeadership\nCollaborate with the engineering, commercial operations, procurement and ancillary groups and wider development, manufacturing, and procurement teams for high priority product-program initiatives.\nAttention to detail and self-motivation to deliver work to the highest standards.\nMulti-tasking, planning work, scheduling tasks, coordinating activities, and managing time efficiently.\nTimely problem-solving using data driven tools and methods.\nPresentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.\nOther - General\n\nAttendance to work is an essential function of this position.\nPerforms other duties as assigned by Manager/Supervisor within device assembly and packaging operations. May assist in the areas of NPI as needed.\nSupport the recruitment, management, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.\nKnowledge of and adherence to all PCI, cGMP, GCP, GAMP, 21CFR, 21CFR Part 11 and Annex 11 policies, procedures, rules, and requirements.\n\nQualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.\nRequired:\nCollege or Trade Degree required (engineering degree or related scientific degree preferred). Must have a minimum of at least three years of experience in an FDA regulated industry with strong preference to medical device or combination products.\nDemonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.\nAdvanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.\nFull Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.\nAnalytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.\nPreferred:\nLean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.\nPossesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.\nPrior experience in technical writing and utilizing root cause analysis tools is required.\nCritical thinking skills along with a strong collaborative approach is required.\nTechnical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.\n*The hiring rate for this position is $97.280.00-$115,520 plus eligibility for an 5% MBP. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.\n#LI-SW1\nJoin us and be part of building the bridge between life changing therapies and patients.\nLet’s talk future\nEqual Employment Opportunity (EEO) Statement:\nPCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.\nAt PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.","datePosted":"2026-04-26T12:27:35.586Z","dateModified":"2026-04-26T12:27:35.586Z","hiringOrganization":{"@type":"Organization","name":"Pcipharmaservices","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Springfield","addressRegion":"IL","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"f9d72739a96b9d44a52de0a2"},"url":"https://jobsearcher.com/jobs/f9d72739a96b9d44a52de0a2"}}