Senior Engineering Investigator — Sterile Manufacturing

Quva; Bloomsbury (NJ); On-site; USD 75,000 - 103,000; Full time

Benefits offered by this job

Health benefits

401k

Paid time off

Job summary

Quva is seeking a Principal Engineering Investigator to lead end-to-end investigations in sterile compounding and injectable manufacturing, ensuring scientific rigor, regulatory alignment, and timely CAPA delivery.

You will collaborate across Manufacturing, Quality, Engineering, and Validation to drive data-driven improvements, write defensible reports, support audits, and foster a culture of accountability and continuous improvement at Quva.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, or Life Sciences; 5–7 years in pharma/sterile injectables.
• Demonstrated success managing investigations, CAPA programs, and technical documentation in a cGMP environment.
• Proficiency with eQMS systems (MasterControl, TrackWise, Veeva) and data analysis tools.

Responsibilities

• Lead end-to-end investigations (OOS, OOT, deviations, data anomalies, lab incidents).
• Ensure investigations are scientifically sound, compliant, and timely per FDA/EMA/regs.
• Collaborate with Manufacturing, QA/QC, Engineering, and Validation for data review and CAPA effectiveness.

Skills

Root Cause Analysis

cGMP Compliance

Data Analysis

Cross-functional Collaboration

Education

Bachelor’s degree in Pharmacy

Tools

MasterControl eQMS

TrackWise

Veeva

MS Office

Job description

Quva is seeking a Principal Engineering Investigator to lead end-to-end investigations in sterile compounding and injectable manufacturing, ensuring scientific rigor, regulatory alignment, and timely CAPA delivery.

You will collaborate across Manufacturing, Quality, Engineering, and Validation to drive data-driven improvements, write defensible reports, support audits, and foster a culture of accountability and continuous improvement at Quva.