US-NC, GMP Partner - Automation API Job 459837900A0-MZ
|Requisition ID 54397BR|
Title GMP Partner - Automation API
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.
Design & develop quality & compliance set-up for the Automation process during the project. Ensure good execution & monitoring according to the FDA Good Manufacturing Practices (GMP) requirements.
* Liaison between Automation team, QA & other packages.
* Lead & coordinate project automation quality deliverables with internal & external stakeholders.
* Oversee & approve user requirements for assigned process track.
* Ensure compliance with Regulations, ISO standards, & corporate & local SOPs.
* Prepare & approve documents in partnership with QA & other packages.
* Support, review & approve complex cross-functional investigations & root-cause analysis.
* Coordinate with QA Compliance Specialists to assure compliance with company procedures & policies.
* Create, review & approve validation & change control documentation.
* Execute project deliverables.
* Report project performance to the relevant stakeholders.
* Develop & implement metrics for Quality System process improvements.
* Provide coaching to QA Compliance & Site regarding quality-related activities.
* Perform plant-wide training on Regulations, Quality systems & procedures.
* Review & approve validation & change control documentation.
* Perform other duties as assigned, e.g. design review & qualification.
•BA/BS in Life Sciences, Engineering, or related field or equivalent combination of education & experience.
•10+ work experience in pharmaceutical manufacturing.
•8+ years of GMP, QA &/or related experience in the pharmaceutical or medical device industry with progressively increasing responsibility.
•Demonstrated expertise in regulations & quality systems (e.g. NC/CAPA, Change Control, Audits, Validation, etc.).
•Familiarity with processes & quality systems within assigned process track.
Technical/Process/Functional Knowledge: MANDATORY
•Experience with Manufacturing Execution Systems, Process Control Systems, Historian, Building Management Systems, PLC & SCADA systems.
•Solid experience in S88, S95 batch model.
•Knowledge within API processes.
•Extended knowledge in GAMP.
•Excellent written & verbal communication skills.
•Basic computer skills in MS Office, MS Project, PowerPoint, etc.
Demonstrated excellence in time management, organizational, & project management skills. Ability to work in a high performance team environment.
Physical & Other Requirements:
•Ability to work in & around an active construction site during project phase.
•Ability to move throughout the facility in the performance of duties in proximity of process equipment & areas.
•Ability to work hours necessary & according to process needs.
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.
Department DAPI US - Automation
Position Location US - Clayton, NC
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.
Please visit our website at www.novonordisk.com