Principal Engineering Investigator

About the role

The Principal Engineering Investigator ensures the accuracy, integrity, and timeliness of all technical investigations and CAPAs associated with sterile compounding and injectable manufacturing operations. This role collaborates with teams to identify true root causes, develop effective and sustainable corrective/preventive actions, and communicate results that withstand regulatory scrutiny. It supports continuous improvement initiatives to enhance quality, compliance, and operational efficiency while fostering a culture of accountability and excellence across Quva.

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, approve, 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 CAPAs with a mindset of driving the process using Poka Yoke solutions to reduce errors and shift focus to continuous improvement opportunities.
• 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.

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, Minitab or JMP; Mind Manager or other brainstorming software preferred).
• Ability to lead/facilitate Kaizen in problem-solving.

Skills

• 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.
• Strong data analysis and trend evaluation capabilities; ability to set up data sets to measure process capability and 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 present to leadership with executive presence.
• Champions a culture of compliance, integrity, and continuous improvement.
• Delivers clear, concise, and scientifically sound documentation and presentations.

Qualifications

• Lean or Six Sigma qualified (preferred).
• Experience with Lean Transformation, specifically McKinsey transformation (a plus).
• Experience supporting 503B outsourcing facilities, sterile injectables, or hospital compounding (preferred).

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.

Pay

The base compensation for this role is estimated to be within the range of $88,792 - $116,838 annually. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions.

About Quva

Quva 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.