CAPA Sr. Associate

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

The CAPA Sr. Associate will support nonconformance investigations CAPA activities root cause analysis technical documentation and effectiveness checks within a regulated pharmaceutical or medical device manufacturing environment.

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:

• Bachelors 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 youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its 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.