Senior Engineering Investigator - CAPA & Quality

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

Benefits offered by this job

Health insurance

401k retirement plan

Paid time off

Job summary

Quva seeks a Principal Engineering Investigator to oversee investigations and CAPAs in sterile compounding and injectable manufacturing. You will lead end-to-end investigations, collaborate with QA, Manufacturing, and Engineering, and communicate results to meet FDA/EMA expectations.

You will apply structured RCA tools, mentor staff, review complex reports, and support audits to drive continuous improvement and reduce process variation across sites.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or related discipline.
• Minimum 5–7 years of experience in pharmaceutical or sterile injectable manufacturing.
• KT Analysis certification is required.

Responsibilities

• Lead end-to-end investigations (OOS, OOT, deviations) with regulatory alignment.
• Collaborate with Manufacturing, QA, QC, Engineering, and Validation to review data and CAPA effectiveness.
• Prepare and review high‑complexity investigation reports and CAPA documentation.

Skills

Root cause analysis

KT Analysis

cGMP compliance

Data analysis

Regulatory documentation

eQMS experience

Technical writing

Microsoft Office

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences

Tools

MasterControl

TrackWise

Veeva

Visio

Excel

Mini-Tab/JMP

Job description

Quva seeks a Principal Engineering Investigator to oversee investigations and CAPAs in sterile compounding and injectable manufacturing. You will lead end-to-end investigations, collaborate with QA, Manufacturing, and Engineering, and communicate results to meet FDA/EMA expectations.

You will apply structured RCA tools, mentor staff, review complex reports, and support audits to drive continuous improvement and reduce process variation across sites.