Senior CAPA Associate — Root Cause & Investigation Expert

Veg Group; Barceloneta (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG) is seeking a CAPA Sr. Associate to support nonconformance investigations and CAPA activities in a regulated pharmaceutical or medical device environment.

The role focuses on root cause analysis, documentation, and effectiveness checks, with potential travel to support multidisciplinary teams. The successful candidate will have a bachelor’s degree in engineering or sciences, 5+ years in pharma/medical device industries, and strong leadership and

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• Minimum 5 years in pharma/medical device; 3 years in similar role; 5+ preferred.
• Strong GMP knowledge and leadership/communication skills.

Responsibilities

• Execute and document nonconformance investigations with root, probable, potential, and contributing causes.
• Develop investigation strategies through cross-functional collaboration and process observation.
• Prepare technical reports including investigation plans, summaries, testing strategies, and root cause hypotheses.
• Coordinate with SMEs for input and ensure timely CAPA records closure.
• Support CAPA actions, effectiveness checks, and continuous improvement initiatives.

Skills

CAPA expertise

Root cause analysis

GMP knowledge

Quality Systems

Leadership

Communication

Bilingual English/Spanish

Education

Bachelor of Engineering/Science

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. (V&EG) is seeking a CAPA Sr. Associate to support nonconformance investigations and CAPA activities in a regulated pharmaceutical or medical device environment.

The role focuses on root cause analysis, documentation, and effectiveness checks, with potential travel to support multidisciplinary teams. The successful candidate will have a bachelor’s degree in engineering or sciences, 5+ years in pharma/medical device industries, and strong leadership and