Test Method Development Engineer - Pharmaceuticals
The Test Method Development Engineer is responsible for evaluating and verifying Life Science Fitness-For-Use product performance and ensuring that the assessment meets industry standards, guidance and best practices. This includes ensuring that new and existing products meet the targeted end use requirements, providing recommendations for post-commercial change product retesting, providing technical expertise and training to industry trade associations and internal groups and exhibiting thought leadership by generating technical reports and white papers.
•Prepare protocols and testing matrix justification for fitness for use and Validation Guide product characterization. Implement known test methods and collaborate with R&D on the development of new test methods.
•Participate in raw material, process and product change teams to provide guidance on process scale fitness for use product testing requirements.
•Generate technical reports and white papers and provide product training to Marketing, Sales, Technical Service and Application Engineering.
•Participate new product development teams. Provide input into industry standards, guidance and best practices for product fitness for use testing. Coordinate Validation Guide new product characterization and fitness for use testing for new product launches.
•Develop and implement a product characterization and fitness for use testing strategy in collaboration with Marketing, Product Management, Technical Services and Application Engineering groups that meets industry standards, guidance and best practices.
•Provide guidance to Application Engineering and Technical Services teams as needed.
•Develop programs for quantifying the impact of product performance and testing conditions on end use applications. Identify best practices for process related fitness for use testing and product characterization.
•Active participation in Industry Trade Groups (BPSA, PDA, ASME, ISPE, AIChE) to maintain up to date knowledge of current industry trends, issues and guidelines relating to the products being supported.
•Bachelor’s degree in Science, Engineering or equivalent.
•3+ years' of experience in testing and validation of Medical devices.
•Experience with biopharmaceutical product validation is a plus.
•Experience with new product development and experimental design concepts.
•Knowledge of process scale fluid flow, mixing and filtration operations is a plus.
•Ability to resolve complex technical problems and make recommendations.
•Excellent written and communication skills.
•Experience and knowledge in the Pharmaceutical industry is a plus.
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