Posted to MedZilla on 6/16/2018

Novo Nordisk

US-NC, EM Process Area Specialist Job 468179100A2-MZ


Your Groundbreaking Journey

At Novo Nordisk, we want to make a difference. For more than 90 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help and improve the quality of life for millions of people around the world.

To help meet the growing demand for our diabetes treatment, Novo Nordisk expects to double production of diabetes drugs over the next decade. Novo Nordisk is currently building a new diabetes API plant in Clayton, NC next to our existing facility that employs 800 people. The new plant will initially employ 700 employees to produce the active ingredients for a new diabetes oral treatment and a range of other diabetes drugs.

Novo Nordisk is currently seeking top talent for this green field project and eventual operations. This once in a life-time career opportunity is ideal for manufacturing professionals who not only understand the operational complexities of manufacturing but also have the desire and drive to help us design and build. Here you will work with the best manufacturing professionals in the industry, while learning and taking part in the plant design.

Position Purpose:
Designs & implements appropriate technical & operational solutions for systems & processes within the scope of Environmental Monitoring, with a special focus on cleaning & sampling programs for new API production facility

Designs & implements technical & operational solutions for EM processes & systems which are consistent with overall project strategy, meet customer requirements & operational needs of the future facility, & are compliant with authority & internal requirements & procedures.
Performs risk assessments & develops system requirement documents (URS, FS, etc.).
Executes validation activities & writes validation protocols & reports.
Develops SOPs & delivers high-quality training.
Collaborates with stakeholders in other departments to develop solutions & solve problems.
Works with procurement to identify & purchase equipment, materials & services needed for Environmental Monitoring program.
Other tasks & responsibilities as assigned.

BA/BS in life sciences, engineering, or similar field. MANDATORY

Experience: PREFERRED
•Minimum 5 years of experience in the pharmaceutical industry working in a GMP-regulated environment, including 2 years of environmental monitoring experience.
•Prior experience working in or managing projects.

Technical/Process/Functional Knowledge: PREFERRED
•Demonstrated knowledge in several of the following areas: facility cleaning, EM sampling, designing & establishing classified areas, risk analysis, qualification/validation, contamination prevention, gowning & behavior, EM data management & trend analysis, developing & delivering EM-related training.

Communication: PREFERRED
•Able to communicate technical information & ideas to a wide variety of audiences.
•Able to adapt communication style to different audiences, including management, regulatory officials, other SMEs, operational personnel, etc.
•Possesses strong technical writing ability & skills.

Organization/Planning: PREFERRED
Proven experience in planning/organizing, managing execution & using resources & time effectively.

Physical & Other Requirements:
•Ability to work in & around an active construction site.
•Ability to work flexible hours to meet customer demands.
•Ability to travel locally & internationally as needed.

At this time, Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.

Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

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.

Sourcing period will close on 15 May 2018.

Requisition ID: 55472BR
State/Provinces: Clayton
Job Category: manufacturing

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