CAPA Sr. Associate

Validation & Engineering Group, Inc.; Aibonito (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc. in the United States is seeking a CAPA Sr.

Associate to lead investigations of nonconformances and drive CAPA initiatives within the pharmaceutical, drug manufacturing, or medical device sectors. You will develop investigation strategies, prepare technical reports, and coordinate with SMEs to implement corrective actions and ensure strict compliance with GMP and Quality Systems.

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 of experience in a similar role; 5+ years preferred.
• Minimum 3 years of supervisory experience; 5+ years preferred.
• Strong knowledge of Quality Systems and GMP.
• TrackWise experience preferred.
• Strong analytical, problem-solving, leadership, communication, influencing, and negotiation skills.
• Fluent in written and spoken English.
• Bilingual English/Spanish.
• Ability to work effectively within multidisciplinary teams.
• Willingness to travel occasionally.

Responsibilities

• Execute and document nonconformance investigations, including 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 input.
• Support identification and implementation of mitigation actions, CAPA, and effectiveness checks.
• 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

Quality Systems

GMP

Root Cause Analysis

CAPA

Leadership

Teamwork

English fluency

Bilingual EN/ES

Education

Bachelor's degree in Engineering/Science

Tools

TrackWise

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• CAPA Sr. Associate

Description

• 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.

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 of experience in a similar role or responsibility; 5+ years preferred.
• Minimum 3 years of supervisory experience; 5+ years preferred.
• Strong knowledge of Quality Systems and Good Manufacturing Practices (GMP).
• TrackWise experience preferred.
• Strong analytical, problem-solving, leadership, communication, influencing, and negotiation skills.
• Fluent in written and spoken English.
• Bilingual English/Spanish.
• Ability to work effectively within multidisciplinary teams.
• Willingness to travel occasionally.

Physical Requirements

• Light work, including occasional lifting of up to 20 lbs and the ability to walk, stand, or perform other physical activities associated with a manufacturing environment.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.