Process Engineer II

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care.

Responsible for the design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. Provides expertise in cell culture, purification, freeze drying, formulation, powder processing, engineering, design, and scale-up. Essential Duties & Responsibilities * Leads process and equipment troubleshooting to support deviations, corrective actions and related issues. * Coordinate fabrication, procurement, installation, engineering start-up, and validation activities of new equipment and systems, including documentation of IQ/OQ protocols, test executions, and summary reports. * Participate in the development and implementation of procedural or automation improvement changes. * Participate in design and hazard reviews of plant expansions or process changes, and serving as the technical point of contact or user representative for contractor services including design, fabrication, installation and validation. * Point person for process improvement activities; including performing or authoring equipment specifications, user and functional requirements specifications, and necessary FAT and SAT protocols. * Initiate and manage projects, tracking spending of budgets, creating scope of work, justification, risk assessments, cost estimates, implementing purchase order requisitions, and controlling payment schedules. * Regular supervision of contractor or intern reports including mentoring, performance reviews, project and support advice as well as troubleshooting for the more complicated issues found in the manufacturing environment. * Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.

Education/Special Training Required Requires a Bachelors/Masters/PhD degree (or equivalent experience) in engineering or related discipline. Qualifications/Work Experience Required * A minimum of six (6) years related experience. Prefer medium to large scale pharmaceutical or biotechnology process experience. * Normally receives no instructions on routine work, general instructions on new assignments. * Knowledge of Automation, GMPs, Compliance and Regulatory requirements is essential. * Excellent communication skills and ability to work in a high-paced team-oriented environment.