Quva · 2 months ago
Principal Engineering Investigator
Bloomsbury, New Jersey, United States
Full-time
Onsite
Senior Level, Lead/Staff
$89K/yr - $117K/yr
5+ years expQuva is a company that provides industry-leading health-system pharmacy services and solutions. They are seeking a Principal Engineering Investigator to ensure the accuracy, integrity, and timeliness of technical investigations and CAPAs related to sterile compounding and injectable manufacturing operations, while supporting continuous improvement initiatives.
Health CareManufacturingMedicalMedical DevicePharmaceutical
Responsibilities
Lead end-to-end analytical and manufacturing-related investigations, including out-of-specification (OOS), out-of-trend (OOT), analytical deviations, data anomalies, and lab incidents
Ensure investigations are scientifically sound, compliant, and completed within defined timelines, meeting all cGMP and regulatory expectations (FDA, EMA, USP <797>/<800>, and 503B guidance)
Apply 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
Collaborate cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams to collect data, review trends, and verify CAPA effectiveness
Review, approval, and/or author high-complexity investigation reports, technical assessments, and CAPA documentation to ensure technical accuracy and regulatory compliance
Identify and trend recurring issues, conducting periodic reviews to drive continuous improvement initiatives that enhance product quality and operational consistency
Perform thorough data review, analytical method assessments, equipment troubleshooting, and sample/laboratory workflow evaluation
Lead investigation, readiness, efforts and support internal and external audits, providing detailed summaries of investigation history, CAPA status, and site performance metrics
Collaborate with stakeholders to implement CAPAs, track progress, and verify effectiveness
Promote a culture of accountability and right-first-time documentation
Train others on Root Cause methodologies
Implement CAPA’s with a mindset of driving the process with a Poke Yoke solution
The 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
Prepare clear, concise, and defensible investigation reports that meet internal quality standards and FDA/EMA regulatory expectations
Support internal, customer, and regulatory inspections by presenting investigation logic, risk reasoning, and CAPA justification
Qualification
Required
Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or related discipline required
Minimum 5-7 years of experience in pharmaceutical or sterile injectable manufacturing
Demonstrated success managing investigations, CAPA programs, and technical documentation in a cGMP-regulated environment
KT Analysis certified
Strong working knowledge of sterile compounding, aseptic processing, cleanroom operations, and environmental control systems
Deep understanding of FDA and EMA inspection expectations, particularly regarding data integrity, documentation practices, and deviation management
Expertise in root cause analysis and problem-solving methodologies
Proficiency with electronic Quality Management Systems (eQMS) such as MasterControl, TrackWise, or Veeva
Strong technical writing and documentation review skills
Proficiency in Microsoft Office Suite and analytical tools (specifically Visio, Excel, Mini-Tab or JMP; Mind Manager or other brainstorming software preferred)
Ability to lead/facilitate Kaizan in problem solving
Preferred
Lean or Six Sigma qualified. Experience with Lean Transformation is a plus, specifically McKinsey transformation
Experience supporting 503B outsourcing facilities, sterile injectables, or hospital compounding preferred
Benefits
Comprehensive health and wellness benefits including medical, dental and vision
401k retirement program with company match
17 paid days off plus 8 paid holidays per year
Company
Quva
Quva is a national, industry-leading provider of health-system pharmacy services and solutions, including 503B sterile injectable outsourcing and data software solutions that generate insights to help power the business of pharmacy.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$356MKey Investors
Goldman SachsBain Capital Ventures
2021-05-06Debt Financing· $275M
2018-07-26Debt Financing· $41M
2018-01-31Private Equity· $15M
Leadership Team
Brian Coyle
Director of National Accounts
Recent News
PR Newswire UK
2025-10-20
Company data provided by crunchbase