Test Methods & Systems Engineer

Support installation, commissioning, qualification, and deployment of test systems. Execute IQ, OQ, and PQ activities. Support test system implementation across manufacturing sites. Perform test method validation and verification activities. Support Design of Experiments (DOE) and statistical analysis. Assist with test method and system transfers between manufacturing locations. Troubleshoot test systems and test method issues. Support equipment maintenance and continuous improvement activities. Support deviation investigations and root cause analysis. Execute change control and implementation activities. Prepare and maintain qualification, validation, engineering, and technical documentation. Support audit readiness and quality compliance activities. Develop and update procedures, work instructions, test programs, and training materials. Support training and knowledge transfer activities. Collaborate with Engineering, Quality, Manufacturing, Project Management, and external suppliers. Support site readiness, technical reviews, and project implementation activities.

2 5 years of relevant engineering experience. Bachelor’s degree in Engineering, Engineering Technology, Science, or a related technical field. Experience with engineering documentation and technical reports. Experience with IQ/OQ/PQ qualification activities. Experience with test methods, test systems, or analytical testing equipment. Experience in pharmaceutical, medical device, biotechnology, or other regulated industries. Knowledge of test method validation and verification. Experience with deviations, root cause analysis, change control, or quality systems. Experience with DOE and statistical analysis is preferred. Strong technical writing, communication, troubleshooting, and problem-solving skills. Ability to work independently and support multiple projects.

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.