Posted to MedZilla on 3/25/2017

Novo Nordisk

US-NC, Environmental Monitoring Technical Area Specialist Job 383554900A2-MZ


Requisition ID 44191BR
Title Environmental Monitoring Technical Area Specialist
Job Category Quality
Job Description 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 the Environmental Monitoring work package, which are consistent with overall project strategy, meet customer requirements & operational needs of the future facility, & are compliant with authority & internal Novo Nordisk requirements & procedures.

Collaborates with other DAPI-US work packages & tracks to design & implement technical & operational solutions for Environmental Monitoring (EM) processes & systems.
Develops SOPs & delivers high-quality training.
Assists EM Work Package Owners (WPO) with project management tasks.
Consults with EM counterparts in DAPI& other parts of Novo Nordisk to identify best practices &, where possible, align on work processes & practices.
Acts as subject matter expert (SME) & advises EM WPO & other members of DAPI-US project team on issues related to EM work package.
Other tasks & responsibilities as assigned.

BA/BS in life sciences, engineering, or similar field; MA/MS preferred.

Minimum 7+ years of experience in the pharmaceutical industry working in a GMP-regulated environment, to include 3 years with environmental monitoring in a pharmaceutical API manufacturing facility.
Prior experience working in or managing medium or large projects in an operational setting or as part of green-field project.

Technical/Process/Functional Knowledge:
Demonstrated expertise in most or all of the following areas: designing & establishing classified areas, risk analysis, qualification/validation, facility cleaning, EM sampling, contamination prevention, gowning & behavior, EM data management & trend analysis, developing & delivering EM-related training.
Solid knowledge of industry trends & best practices related to pharmaceutical cleanrooms & environmental monitoring.

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.

Department DAPI US - Purification
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC

At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness

With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!

Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.

Novo Nordisk will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

If you are interested in applying for employment with Novo Nordisk and need special assistance or an accommodation to use our website or to apply for a position, please call the U.S. Toll Free number at 1-855-411-5290 or click on the following link to submit your request: Please note we do not accept applications for employment or employment related solicitations through this site. If you are requesting special assistance, please specify your request by selecting "Yes" in Question 2 on the site. We will not be able to respond to requests unless you specify the need for special assistance or an accommodation in Question 2. Determinations on requests for reasonable accommodation are made on a case-by-case basis.

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