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Quva · 10 hours ago

Principal Engineering Investigator

Bloomsbury, NJ

Full-time

Onsite

Senior Level, Lead/Staff

$89K/yr - $117K/yr

5+ years exp

Quva is an industry-leading health-system pharmacy services provider, and they are seeking a Principal Engineering Investigator to ensure the accuracy and integrity of technical investigations related to sterile compounding and injectable manufacturing operations. This role involves leading investigations, collaborating across teams, and driving continuous improvement initiatives to enhance product quality and operational efficiency.

Health CareManufacturingMedicalMedical DevicePharmaceutical

Comp. & Benefits

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 /, 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

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

Root Cause AnalysisCAPA ManagementAseptic ManufacturingRegulatory ComplianceData AnalysisEQMS ProficiencyLean Six SigmaTechnical WritingMentoringProblem SolvingCollaboration

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.

Founded in 2015

Sugar Land, Texas, USA

1001-5000 employees