Principal Engineering Investigator

Quva • Bloomsbury, NJ

22d

About The Position

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. What the Principal Engineering Investigator Does Each Day: 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 Our Most Successful Principal Engineering Investigator: Has deep understanding of aseptic manufacturing processes and regulatory standards Ability to mentor, coach, and develop high-performing technical staff Applies sound judgment in resolving complex technical and quality issues Has strong data analysis and trend evaluation capabilities. Ability to set data sets up to measure process capability, control charts for ongoing monitoring/effectiveness Builds 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 Champions a culture of compliance, integrity, and continuous improvement Delivers clear, concise, and scientifically sound documentation and presentations

Requirements

• 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

Nice To Haves

• 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

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
• 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

Benefits

• Set, full-time, consistent work schedule
• 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
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Principal