Senior CAPA Lead: Root Cause & Compliance Expert

Veg Group; Barceloneta (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

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

The role requires a Bachelor’s degree and 5+ years in pharma/medical devices, with 3+ years in a similar role and supervisory experience. English fluency and travel flexibility are essential as part of a multidisciplinary team.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• Minimum 5 years of experience in the pharmaceutical, drug manufacturing, or medical device industry; minimum 3 years in a similar role; 5+ years preferred.
• Minimum 3 years of supervisory experience; 5+ years preferred.
• Strong knowledge of GMP and Quality Systems; TrackWise experience preferred.
• Fluent in written and spoken English; bilingual English/Spanish.
• Willingness to travel occasionally.

Responsibilities

• Execute and document nonconformance investigations, including identification of root, probable, potential, and contributing causes.
• Develop investigation strategies through multidisciplinary collaboration, process observations, product/sample evaluations, interviews, and follow-up activities.
• Prepare clear technical reports, including investigation plans, executive summaries, testing strategies, root cause hypotheses, and investigation results.
• Apply Root Cause Analysis tools and coordinate with SMEs to obtain scientific and technical input.
• Support identification and implementation of mitigation actions, Corrective and Preventive Actions, and Effectiveness Check criteria.
• Partner with Investigation and CAPA approvers to support timely execution and closure of records.
• Participate in CAPA review boards and continuous improvement initiatives.
• Provide coaching, mentoring, and guidance related to Nonconformance and CAPA processes.
• Promote compliance with applicable EHS practices and a zero-harm workplace.

Skills

Analytical thinking

Problem-solving

Leadership

Communication

Negotiation

Bilingual English/Spanish

Education

Bachelor’s degree in Engineering/Science

Tools

TrackWise

Job description

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

The role requires a Bachelor’s degree and 5+ years in pharma/medical devices, with 3+ years in a similar role and supervisory experience. English fluency and travel flexibility are essential as part of a multidisciplinary team.