Quality Engineer: Validation & Compliance Excellence

Philip Morris International U.S.; Aurora (CO); On-site; USD 81,000 - 101,000; Full time

Job summary

Philip Morris International (PMI) is seeking a Quality Engineer to support validation, compliance, and quality initiatives across manufacturing operations. You will partner with cross-functional teams to maintain qualified systems, ensure regulatory compliance, and drive product quality and operational excellence.

The position requires a Bachelor's degree in a related field and 3+ years of experience in a regulated environment, with a strong emphasis on GMPs and data integrity.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biological Sciences, Manufacturing, Quality, or a related field.
• 3+ years of experience in Quality, Engineering, Validation, Manufacturing, or another regulated industry.
• Experience in FMCG, tobacco, pharmaceutical, food, medical device, or similar regulated manufacturing environments preferred.

Responsibilities

• Ensure compliance with quality standards, internal procedures, and regulatory requirements.
• Support audit readiness and participate in internal, customer, and regulatory inspections.
• Promote a culture of safety and continuous improvement.
• Lead validation and qualification activities for manufacturing, laboratory, utility, and computerized systems.
• Manage validation documentation, change control, lifecycle compliance, and data integrity requirements.
• Conduct risk assessments, support mitigation activities, and evaluate quality impacts of changes.
• Investigate non-conformances, perform root cause analysis, and drive CAPA effectiveness.
• Monitor product and process performance trends to identify risks and improvement opportunities.
• Support quality system enhancements through data analysis, standardization, and best practices.
• Provide technical quality support for new products, process changes, equipment qualifications, and training initiatives.

Skills

Quality

Engineering

Validation

GMPs

Education

Bachelor’s degree

Job description

Philip Morris International (PMI) is seeking a Quality Engineer to support validation, compliance, and quality initiatives across manufacturing operations. You will partner with cross-functional teams to maintain qualified systems, ensure regulatory compliance, and drive product quality and operational excellence.

The position requires a Bachelor's degree in a related field and 3+ years of experience in a regulated environment, with a strong emphasis on GMPs and data integrity.