Process Engineer II - Biotech Manufacturing

The Position

Responsible for the design and implementation of manufacturing processes, instrumentation and equipment start-ups from the laboratory through manufacturing scale. This individual provides expertise in cell culture, purification, freeze drying, formulation, powder processing, engineering, design, and scale-up. This role supports actions coming out of deviation investigations & CAPAs within our GMP manufacturing operations at our commercial pharmaceutical bioproduction plant.

Essential Functions

• 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
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others
• Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

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Qualifications

Education and Certifications : - Requires a Bachelors / Masters / PhD degree (or equivalent experience) in engineering or related discipline

Work Experience : - A minimum of five (5) years related experience with a Bachelor’s or three (3) years related experience with a Master’s or higher. Prefer medium to large scale pharmaceutical or biotechnology process experience

Knowledge, Skills, and Abilities : - Normally receives no instructions on routine work, general instructions on new assignments

Knowledge of Automation, GMPs, Compliance, and Regulatory requirements is essential

Physical Requirements

The ability to climb. stoop, kneel, crouch, crawl, reach, stand, and walk. The ability to push, pull, lift, finger, feel, and grasp. The ability to speak, listen, and understand verbal and written communication. Repetition including substantial movement of wrists, hands, and or fingers. Lifting up to 33lbs / 15kg of force occasionally, and / or up to 30 pounds of force frequently, and / or up to 10 pounds of force constantly to move objects. Visual acuity to perform close activities such as : reading, writing, and analyzing; and visual inspection. The working environment includes a variety of physical conditions including noise, inside and outside conditions, working in narrow aisles, and temperature changes; atmospheric conditions including : odors, fumes, and dust. Local and International Travel : 0-10%.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

You should be proficient in :

ID : 8SR6Ct