The Qualification Engineer will ensure all equipment used to manufacture products at Noven Pharmaceuticals meets its design requirements and is qualified for its intended purpose. This entails oversight of equipment design including URS, FAT, and SAT, and the design, execution, and summarization of equipment installation and operational qualification protocols. The position will interact mainly with the Engineering and Quality Engineering departments, as well as, process qualification resources.
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. 2-4 years of 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 equal time spent sitting at desk or 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.