Senior CAPA Investigator & Process Improvement

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

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks a CAPA Sr.

Associate to support nonconformance investigations, CAPA activities, root cause analysis, and documentation within a regulated pharmaceutical or medical device manufacturing environment. The role emphasizes cross-functional collaboration, timely closure of records, and implementation of corrective actions while upholding GMP and quality systems.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Minimum 5 years of experience in the pharmaceutical, drug manufacturing, or medical device industry. Minimum 3 years of supervisory experience; 5+ years preferred.
• Strong knowledge of Quality Systems and GMP; TrackWise experience preferred.

Responsibilities

• Execute and document nonconformance investigations, including root, probable, potential, and contributing causes.
• Develop investigation strategies through multidisciplinary collaboration, observations, interviews, and follow-up activities.
• Prepare clear technical reports including investigation plans, executive summaries, testing strategies, root cause hypotheses, and results.
• Apply Root Cause Analysis tools and coordinate with SMEs for input.
• Support identification and implementation of corrective and preventive actions and effectiveness checks.
• Partner with Investigation and CAPA approvers for timely execution and closure of records.
• Participate in CAPA review boards and continuous improvement initiatives.
• Provide coaching relating to Nonconformance and CAPA processes.
• Promote compliance with applicable EHS practices and a zero-harm workplace.

Skills

English (Fluent)

Leadership

Communication

Education

Bachelor’s degree in Engineering or Science

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. in Puerto Rico seeks a CAPA Sr.

Associate to support nonconformance investigations, CAPA activities, root cause analysis, and documentation within a regulated pharmaceutical or medical device manufacturing environment. The role emphasizes cross-functional collaboration, timely closure of records, and implementation of corrective actions while upholding GMP and quality systems.