{"id":3323088,"url":"https://alion.io/job/onequva-principal-engineering-investigator","title":"Principal Engineering Investigator","company":{"id":3832669,"name":"Onequva","domain":"onequva.com","url":"https://alion.io/company/onequva","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":null},"role":"Operations","role_family":"Operations","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bloomsbury, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":85000,"max_usd":196000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1314},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"FMEA","optional":false},{"name":"GMP","optional":false},{"name":"JMP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Veeva","optional":false},{"name":"Machine Learning","optional":true}],"status":"live","first_seen_at":"2026-09-29T14:50:17Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-11-01T20:11:23Z","board_verified":true,"closed_at":null,"days_open":33,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":33},"description":"Principal Engineering Investigator exists to ensure the accuracy, integrity, and timeliness of all technical investigations and CAPAs associated with sterile compounding and injectable manufacturing operations. This role is accountable for collaborating with the team that identifies true root causes, develops effective and implements sustainable corrective/preventive actions, and communicates results that withstand regulatory scrutiny. The role is pivotal in supporting continuous improvement initiatives that enhance and transform the quality, compliance, and operational efficiency while fostering a strong culture of accountability and excellence across Quva. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.\nWhat the Principal Engineering Investigator Does Each Day:\nLead end-to-end analytical and manufacturing-related investigations, including out-of-specification (OOS), out-of-trend (OOT), analytical deviations, data anomalies, and lab incidents\nEnsure investigations are scientifically sound, compliant, and completed within defined timelines, meeting all cGMP and regulatory expectations (FDA, EMA, USP /, and 503B guidance)\nApply structured problem-solving tools (e.g., 5 Whys, Fishbone Diagram, Fault Tree, FMEA, KT Analysis) to determine true root causes and recommend durable corrective and preventive actions\nCollaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams to collect data, review trends, and verify CAPA effectiveness\nReview, approval, and/or author high-complexity investigation reports, technical assessments, and CAPA documentation to ensure technical accuracy and regulatory compliance\nIdentify and trend recurring issues, conducting periodic reviews to drive continuous improvement initiatives that enhance product quality and operational consistency\nPerform thorough data review, analytical method assessments, equipment troubleshooting, and sample/laboratory workflow evaluation\nLead investigation, readiness, efforts and support internal and external audits, providing detailed summaries of investigation history, CAPA status, and site performance metrics\nCollaborate with stakeholders to implement CAPAs, track progress, and verify effectiveness\nPromote a culture of accountability and right-first-time documentation\nTrain others on Root Cause methodologies\nImplement CAPA’s with a mindset of driving the process with a Poke Yoke solution\nThe end state of the role is to reduce errors to the point where they can shift to more continuous improvement opportunities and release capacity and capture business opportunities as a result of their efforts\nPrepare clear, concise, and defensible investigation reports that meet internal quality standards and FDA/EMA regulatory expectations\nSupport internal, customer, and regulatory inspections by presenting investigation logic, risk reasoning, and CAPA justification\nOur Most Successful Principal Engineering Investigator:\nHas deep understanding of aseptic manufacturing processes and regulatory standards\nAbility to mentor, coach, and develop high-performing technical staff\nApplies sound judgment in resolving complex technical and quality issues\nHas strong data analysis and trend evaluation capabilities. Ability to set data sets up to measure process capability, control charts for ongoing monitoring/effectiveness\nBuilds effective partnerships across cross-functional teams. Ability to work with the shop floor to engage in problem solving and also have executive presence to present to leadership\nChampions a culture of compliance, integrity, and continuous improvement\nDelivers clear, concise, and scientifically sound documentation and presentations\nMinimum Requirements for this Role:\nBachelor’s degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or related discipline required\nMinimum 5-7 years of experience in pharmaceutical or sterile injectable manufacturing\nDemonstrated success managing investigations, CAPA programs, and technical documentation in a cGMP-regulated environment\nKT Analysis certified\nStrong working knowledge of sterile compounding, aseptic processing, cleanroom operations, and environmental control systems\nDeep understanding of FDA and EMA inspection expectations, particularly regarding data integrity, documentation practices, and deviation management\nExpertise in root cause analysis and problem-solving methodologies\nProficiency with electronic Quality Management Systems (eQMS) such as MasterControl, TrackWise, or Veeva\nStrong technical writing and documentation review skills\nProficiency in Microsoft Office Suite and analytical tools (specifically Visio, Excel, Mini-Tab or JMP; Mind Manager or other brainstorming software preferred)\nAbility to lead/facilitate Kaizan in problem solving\nAny of the Following Will Give You an Edge:\nLean or Six Sigma qualified. Experience with Lean Transformation is a plus, specifically McKinsey transformation\nExperience supporting 503B outsourcing facilities, sterile injectables, or hospital compounding preferred\nBenefits of Working at Quva:\nSet, full-time, consistent work schedule\nComprehensive health and wellness benefits including medical, dental and vision\n401k retirement program with company match\n17 paid days off plus 8 paid holidays per year\nNational, industry-leading high growth company with future career advancement opportunities\nThe base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions\nRange: $74,66- $102,812 Annually\nAbout Quva:\nQuva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.\nQuva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. 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