The Principal MTS Engineer will oversee the IQ/OQ/PQ processes including qualification project management, procedural guidance, equipment engineering studies, drafting and executing protocols, and report writing. This position will be the technical lead for qualification at Noven Pharmaceuticals and provide insight into the latest statistical and efficiency techniques for equipment and process qualification. The position responsibility includes cross functional collaboration in the equipment design phase including URS, FAT, and SAT, and the design, execution, and summarization of IQ/OQ/PQ protocols. This position will understand the products and processes at Noven Pharmaceuticals and understand equipment impact on products. The position will interact mainly with the Engineering and Quality Engineering departments, as well as, process engineers in the MTS department bringing equipment design and operational expertise.
Education & Experience:
Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering preferred. Bachelor’s degree in other Engineering or Science discipline with relevant equipment understanding. Candidate will possess proven track record of successful equipment qualification including effective and on-time applications. 8-12 years or more, professional experience in a regulated environment. Knowledge of transdermal pharmaceuticals and manufacturing a plus. Experience in project or team management. Excellent written and verbal communication skills; able to establish and maintain professional relationships. Keen attention to detail. Experience with domestic (FDA) and/or international health authorities' (MCA, IMB, JP, EU, etc) regulations, GMP, and ISO guidelines desired.
Air-conditioned office or manufacturing facility environment. Roughly 70% sitting at desk, 30% standing / sitting in a manufacturing environment. Priorities often shifting, with frequent interruptions and tight deadlines; extra hours occasionally required.
Occasionally required to stand for more than two hours at a time. Occasionally lift and carry objects weighing up to twenty pounds. Visual acuity and manual dexterity required to perform experiments, operate computer and proofread documents.