Quality Engineer | Pharmaceutical | El Paso, TX | On Site

Location: El Paso, TX

Position Summary

The Quality Engineer will support pharmaceutical manufacturing operations by ensuring that processes, equipment, and quality systems meet FDA, cGMP, and company quality requirements. This role will collaborate with Manufacturing, Validation, Engineering, and Quality Assurance teams to resolve quality issues, support qualification and validation activities, manage quality risks, and drive continuous improvement.

Main Responsibilities

• Provide Quality Engineering support to pharmaceutical manufacturing processes, equipment, and facilities.

• Investigate deviations, non-conformances, and manufacturing quality issues using structured root cause analysis.

• Develop and support corrective and preventive actions (CAPAs), including implementation and effectiveness verification.

• Assess change controls for potential impacts on product quality, validated systems, and manufacturing processes.

• Support equipment qualification and process validation activities, including review of protocols, acceptance criteria, test results, and reports.

• Participate in quality risk assessments and Failure Mode and Effects Analysis (FMEA).

• Analyze quality metrics and manufacturing data to identify trends, recurring issues, and opportunities for process improvement.

• Collaborate with Engineering and Manufacturing teams to establish process controls and reduce quality defects.

• Review technical documentation, SOPs, specifications, and validation records for compliance and completeness.

• Support internal audits, regulatory inspections, and resolution of quality observations.

• Participate in continuous improvement initiatives to strengthen process reliability and quality performance.

• Maintain accurate and timely documentation within electronic quality management systems.

General Requirements

• Experience working in pharmaceutical manufacturing or a comparable GMP-regulated environment.

• Strong knowledge of FDA regulations, cGMP requirements, and quality management systems.

• Experience with deviations, CAPA, change control, non-conformances, and investigations.

• Strong analytical skills and experience applying root cause analysis tools, such as 5 Whys and fishbone diagrams.

• Understanding of equipment qualification, process validation, and risk management principles.

• Ability to interpret technical documentation, manufacturing data, and quality trends.

• Strong attention to detail, problem-solving skills, and documentation practices.

• Ability to collaborate effectively with Manufacturing, Engineering, Validation, and Quality teams.

• Strong written and verbal communication skills.

• Proficiency with Microsoft Office and electronic quality management systems.

• Ability to work on-site, full-time in El Paso, Texas.

Education and Experience Requirements

• Bachelor’s degree in Engineering, preferably Chemical, Mechanical, Industrial, Biomedical, or a related technical discipline.

• 3+ years of experience in Quality Engineering, Manufacturing Quality, Validation, or a closely related role within the pharmaceutical, biotechnology, or GMP-regulated manufacturing industry.

• Demonstrated experience supporting investigations, root cause analysis, CAPAs, and change controls.

• Experience supporting equipment qualification, process validation, or manufacturing process improvements.

• Experience with quality risk assessments, FMEA, statistical analysis, or statistical process control is preferred.

• Experience supporting regulatory inspections and GMP audits is preferred.

• ASQ Certified Quality Engineer (CQE), Six Sigma, or a related certification is a plus.

• Bilingual English/Spanish is a plus.