GMP Process Quality Engineer - RCA, CAPA & Lean

Virtue America; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

Virtue America is seeking a Process Quality Engineer to support manufacturing processes and quality systems within a regulated pharmaceutical environment. The role collaborates with Manufacturing, QA, QC, Validation, and Engineering to identify risks, investigate issues, and improve product performance.

The ideal candidate has 0–3 years of experience in a regulated industry and a bachelor’s degree in a related field, with strong analytical and problem-solving skills and a quality mindset to

Qualifications

• Bachelor's degree in a related engineering/ sciences field.
• 0–3 years of experience in Quality Engineering, Process Engineering, Manufacturing, or a regulated industry.
• Basic knowledge of GMP, CAPA, deviations, change control, and process validation.

Responsibilities

• Support quality activities related to manufacturing and production processes.
• Investigate process deviations, non-conformances, and quality issues.
• Perform root cause analysis and support CAPA implementation.
• Monitor process and quality trends to identify improvement opportunities.
• Support process validation and qualification activities.
• Review batch records, SOPs, specifications, and manufacturing documentation.
• Assist with change controls and quality impact assessments.
• Support risk assessments such as FMEA.
• Participate in continuous improvement and Lean/Six Sigma initiatives.
• Ensure compliance with GMP/cGMP, FDA regulations, and company quality procedures.
• Collaborate with QA, QC, Manufacturing, Validation, and Engineering teams.
• Support internal audits and regulatory inspection readiness.

Skills

Analytical skills

Problem solving

Team collaboration

Quality mindset

Education

Bachelor's degree (Chemical, Mechanical, Industrial, Biomedical Engineering, Pharmaceutical Sciences, Biotechnology, or related field)

Job description

Virtue America is seeking a Process Quality Engineer to support manufacturing processes and quality systems within a regulated pharmaceutical environment. The role collaborates with Manufacturing, QA, QC, Validation, and Engineering to identify risks, investigate issues, and improve product performance.

The ideal candidate has 0–3 years of experience in a regulated industry and a bachelor’s degree in a related field, with strong analytical and problem-solving skills and a quality mindset to