Pharma Testing Systems Engineer: Failure Analysis & GMP

Stark Pharma Solutions Inc; Columbus (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc. in Ohio seeks a Testing Systems Engineer to provide technical ownership of quality-critical pharmaceutical testing systems. The role focuses on failure investigation, data analysis, test methods, and assessing product-quality impact.

You will collaborate with Quality, Manufacturing, Engineering, Maintenance, and Operations to investigate deviations, nonconformances, and CAPAs, while maintaining documentation and improving testing controls.

Qualifications

• Experience in pharmaceutical or GMP-regulated manufacturing.
• Experience with testing systems, analytical testing, or quality-critical equipment.
• Strong experience in failure investigation, troubleshooting, root-cause analysis.
• Hands-on experience with Zwick/Roell testing machines.
• Experience analyzing force/displacement data, test results, acceptance criteria, and failure conditions.
• Strong Excel and data-analysis skills.
• Experience supporting deviations, CAPAs, nonconformances, or quality investigations.
• Strong understanding of GMP and quality requirements.
• Excellent analytical, communication, documentation, and cross-functional collaboration skills.

Responsibilities

• Own pharmaceutical testing systems technically as the owner.
• Develop understanding of testing methods, procedures, parameters, acceptance criteria, software, and test data.
• Investigate testing failures, alarms, unexpected results, and system anomalies.
• Analyze test data to determine potential product, equipment, software, method, operator, or environmental causes.
• Evaluate whether testing failures represent true product failures or potential testing-system anomalies.
• Support investigations, deviations, nonconformances, CAPAs, and quality events.
• Analyze historical testing data to identify trends, recurring failures, and systemic issues.
• Evaluate test method repeatability, reproducibility, and consistency.
• Review testing-system configurations, fixtures, measurement components, and data outputs.
• Partner with Quality, Manufacturing, Engineering, Maintenance, and Operations teams during investigations.
• Provide evidence-based technical assessments to support quality and batch-impact evaluations.
• Document investigation findings, technical conclusions, root causes, and recommended actions.
• Support improvements to testing methods, procedures, and system controls.
• Maintain technical documentation related to testing systems, methods, investigations, and changes.

Skills

Failure investigation

Data analysis

GMP knowledge

Analytical testing

Excel

Cross-functional collaboration

Troubleshooting

Root cause analysis

Tools

Zwick/Roell

Job description

Stark Pharma Solutions Inc. in Ohio seeks a Testing Systems Engineer to provide technical ownership of quality-critical pharmaceutical testing systems. The role focuses on failure investigation, data analysis, test methods, and assessing product-quality impact.

You will collaborate with Quality, Manufacturing, Engineering, Maintenance, and Operations to investigate deviations, nonconformances, and CAPAs, while maintaining documentation and improving testing controls.