What are the responsibilities and job description for the Test Method Validation Engineer position at Infotree Global Solutions?
The ideal candidate for this Test Method Validation Engineering role will have a Bachelor’s degree in Engineering (Mechanical Engineering preferred) with at least 2 year of industry experience (internship experience is acceptable). They should have a solid understanding of measurement concepts and engineering measurements, as well as basic knowledge of statistics, including confidence intervals and statistical analysis tools. While direct experience in test method validation is preferred, candidates with strong analytical skills and the ability to learn quickly will be considered. Candidates with experience in regulated industries such as pharmaceuticals, medical devices, or other compliance-driven environments will have an advantage, as 70% of the role involves documentation and regulatory compliance. Familiarity with RQPQ (Risk, Qualification, Process Qualification), Installation Qualification (IQ), and Operational Qualification (OQ, PQ) is beneficial but can be developed on the job. Strong problem-solving skills, adaptability, and a demonstrated ability to work in a highly regulated and collaborative environment are key for success in this role.
Description :
Test Method and Validation Engineer Position. This position involves support of senior staff in design, development, modification, qualification, validation, and transfer of the test methods for drug delivery combination products and their subassemblies, including drug product containers and packaging components. The particular focus would be on automated dimensional measurements methods, advanced methods for measuring functional attributes of injection systems and enhancing the visual inspection methods. Candidates are expected to have basic engineering skills with a bachelor’s degree in engineering from an accredited university. They are also expected to have strong technical writing skills and be familiar with different engineering measurement techniques and equipment. Candidates having a master’s degree in mechanical or electrical engineering with the following skills are preferred : statistical analysis, knowledge of Gage R&R, optical and automated measurement devices, test method development, CAD design, Solidworks, mechanical modeling, manufacturing experience, IQ, OQ, and PQ. Teamworking and communication skills is required
