Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
SOC: 17-2112.02
Common Job Titles
Quality Assurance Engineer
Quality Engineer
Quality Management Systems Engineer
Supplier Quality Engineer
What You'll Need to Succeed
AI-generated
Key competencies for this occupation at a glance
KnowledgeEvaluate equipment and process performance data against purity, safety, and quality standards in regulated manufacturing environments, using analytical tools and compliance frameworks.
Advanced
KnowledgeDesign validation protocols for equipment qualification and process validation applying engineering principles and regulatory requirements across manufacturing systems.
Advanced
KnowledgeDevelop test plans and acceptance criteria for validation activities integrating risk assessment methodologies and stakeholder requirements.
Advanced
KnowledgeFormulate corrective action and process improvement recommendations based on root cause analysis of validation failures and non-conformances.
Advanced
KnowledgeAnalyze production process data and test results using statistical software and analytical instruments to identify deviations and trends.
Proficient
KnowledgeAssess compliance of manufacturing processes with FDA, GMP, and industry regulations through inspection and documentation review in pharmaceutical or biotechnology settings.
Proficient
KnowledgeInterpret complex validation data and technical specifications for cross-functional teams including manufacturing, quality assurance, and regulatory affairs.
Proficient
MindsetIntegrate quality and safety principles with production efficiency objectives when collaborating with engineering and operations teams on validation projects.
Proficient
KnowledgeApply analytical methods and instrumentation techniques using spectrophotometers, flow sensors, and programmable logic controllers for process monitoring.
Proficient
MindsetAdvocate for validation best practices and regulatory compliance standards when training personnel and consulting with project stakeholders.
Proficient
KnowledgeOrganize validation documentation and change control records using laboratory information management systems and electronic document management platforms.
Proficient
Wage Data According to the Bureau of Labor Statistics
Annual wage data for Validation Engineers (2024)
Estimated Total Employment (U.S.)
350,230
Wage Distribution by Percentile
Line chart of annual wages by percentile. U.S. is the solid line. 10th percentile: U.S. $70,000. 25th percentile: U.S. $81,910. 50th percentile: U.S. $101,140. 75th percentile: U.S. $127,480. 90th percentile: U.S. $157,140. Use the left and right arrow keys to move between percentiles.
U.S.
Metric
U.S.
10% of workers earn the following or less
$70,000
10% of workers earn the following or more
$157,140
Workers on average earn
$107,900
+ indicates wage is at or above the BLS reporting cap ($239,200/year)
Skills & Requirements
Key competencies for this occupation, ranked by importance
Engineering and Technology4.3/5
Production and Processing4.2/5
English Language3.8/5
Customer and Personal Service3.7/5
Mathematics3.6/5
Skills & Requirements: Knowledge
Tools & Technology
Equipment and software commonly used in this occupation
