Onsite Pharma Quality Engineer El Paso CAPA & Validation

LEGAL PROJECT MANAGEMENT PARTNERS LLC

El Paso (TX)

On-site

USD 76,000 - 83,000

Full time

43 hours ago
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Job summary

LEGAL PROJECT MANAGEMENT PARTNERS LLC in El Paso, TX is seeking a Quality Engineer to support pharmaceutical manufacturing operations on site. You will ensure processes, equipment, and quality systems meet FDA, cGMP, and company requirements while collaborating with Manufacturing, Validation, Engineering, and QA teams.

The role focuses on deviation investigations, CAPAs, change controls, risk assessments (FMEA), data analysis, and documenting of qualifications and validation activities to

Qualifications

  • Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, Biomedical, or related).
  • 3+ years in Quality Engineering or GMP-regulated manufacturing.
  • Experience with deviations, CAPA, change control, investigations.
  • Ability to analyze quality trends and data.
  • ASQ CQE or Six Sigma certification is a plus.

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.

Skills

Root cause analysis
FMEA
CAPA
Documentation
Collaboration

Education

Bachelor’s degree in Engineering

Tools

Microsoft Office
eQMS

Job description

LEGAL PROJECT MANAGEMENT PARTNERS LLC in El Paso, TX is seeking a Quality Engineer to support pharmaceutical manufacturing operations on site. You will ensure processes, equipment, and quality systems meet FDA, cGMP, and company requirements while collaborating with Manufacturing, Validation, Engineering, and QA teams.

The role focuses on deviation investigations, CAPAs, change controls, risk assessments (FMEA), data analysis, and documenting of qualifications and validation activities to

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