Testing Systems Engineer

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Ohio

Long Term

We are seeking a Testing Machine System Owner with experience in pharmaceutical manufacturing, testing systems, and GMP-regulated environments. This role will provide technical ownership of a quality-critical testing system, with a strong focus on failure investigation, data analysis, test methods, system performance, and product-quality impact assessment.

• Serve as the technical owner for pharmaceutical testing systems.
• Develop a strong 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.

• Relevant experience in pharmaceutical or other GMP-regulated manufacturing environments.
• Experience with testing systems, analytical testing, or quality-critical manufacturing equipment.
• Strong experience in failure investigation, troubleshooting, root-cause analysis, and problem-solving.
• Hands-on Experience With Zwick/Roell Testing Machines Is Highly Preferred.
• Experience analyzing force/displacement data, test results, acceptance criteria, and failure conditions.
• Understanding of test fixtures, load cells, measurement systems, and data acquisition.
• Experience with testing-system software, alarms, and data reporting.
• 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.