Posted to MedZilla on 2/17/2018

Novo Nordisk

US-NC, API Manufacturing Associate III Job 455971500A0-MZ


Requisition ID 53686BR
Title API Manufacturing Associate III
Job Category Manufacturing
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.

Must be able to travel internationally for at least 90 days.

Additional Information There are 20 positions total between Fermentation, Recovery & Purification.

Position Purpose: Operate API manufacturing equipment to achieve production goals.

* Work in a safe & environmentally responsible manner.
* Follow instructions listed in GMP documentation & responsible for product quality as described.
* Review & author SOP’s & other documents, as required.
* Staff Coordination with Shift Manager.
* Execute equipment maintenance activities including restoration of lost function, predictive & preventative maintenance (coached by process engineer/maintenance tech).
* Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards.
* Manage individual training plan & train fellow employees in areas of expertise.
* Aggressively learn systems & equipment outside of own expertise.
* Participate in qualification & validation activities as required.
* Proficiency in highly automated equipment related to setup, operation, monitoring & control of systems & processes.
* Execute production schedule to achieve production goals.
* Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance.
* Maintain clean room areas & perform environmental monitoring, as required.
* Record/review production data in BPR, log books & other associated forms. & review all data for entire team.
* Ensure all errors are addressed & corrected real time ensuring compliance with cGMPs.
* Other accountabilities, as assigned.

* High school graduate or equivalent. Mandatory
* BA/BS degree or higher in related field &/or a minimum of 10 years of experience in an FDA regulated manufacturing industry.
* BioWork or equivalent.

* Experience with Fermentation, Centrifuges, Chromatography or similar equipment preferred.
* Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts.
* Actively participated in & driven event response activities.
* Documented problems & worked on ensuring rapid resolution & preventing recurrence.

Technical/Process/Functional Knowledge:
* Basic knowledge of biology/chemistry.
* Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail.
* Ability to perform basic material handling tasks & safely & effectively use material handling equipment.
* Experience with electronic batch records, automated process equipment, &/or DeltaV or Syncade.
* Computer literacy including, but not limited to the ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs. Mandatory

* Proven expertise in planning/organizing, managing execution, checking results & revising work plan in accordance with daily plan.
* Direct interaction in supporting stakeholders & potentially assisting with coordination of planned & corrective maintenance activities to ensure successful process turnaround/performance.

Physical & Other Requirements:
* Ability to work in & around an active construction site during project phase & production equipment during non-project phase activities..
* Ability to lift up to 35 lbs. with assistance.
* Ability to work hours necessary to support production, including ability to stand on feet up to 12 hours or longer, day or night.
* Corrected vision to 20/30.Ability to work in loud noise environments with hearing protection.

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

Novo Nordisk is not currently hiring individuals for this position who now or in the future would require sponsorship for employment visa status.
Department DAPI US Process Support Recovery
Position Location US - Clayton, NC
City Clayton
State/Provinces US - NC
Job/Position Country US

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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