Senior CAPA Investigator - Pharma & Medical Devices

Veg Group; Aibonito (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

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

You will develop investigation strategies, prepare clear technical reports, and coordinate with SMEs to obtain input. The role emphasizes CAPA actions, cross-functional collaboration, and ongoing improvement while promoting a zero-harm workplace.

Qualifications

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

Responsibilities

• Execute and document nonconformance investigations and root cause analyses.
• Develop investigation strategies through multidisciplinary collaboration.
• Prepare technical reports with plans, summaries, and results.
• Apply Root Cause Analysis tools and coordinate with SMEs.
• Support identification and implementation of CAPA actions and effectiveness checks.
• Partner with Investigation and CAPA approvers for timely closure.
• Participate in CAPA review boards and continuous improvement initiatives.
• Provide coaching on Nonconformance and CAPA processes.
• Promote compliance with EHS practices and zero-harm goals.

Skills

Analytical thinking

Leadership

Communication

Problem-solving

Teamwork

Education

Bachelor's degree in Engineering or Science

Job description

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

You will develop investigation strategies, prepare clear technical reports, and coordinate with SMEs to obtain input. The role emphasizes CAPA actions, cross-functional collaboration, and ongoing improvement while promoting a zero-harm workplace.