Posted to MedZilla on 7/14/2018

Novo Nordisk

US-NC, GMP Partner- Building Management Systems (BMS) Quality Automation Job 487407700A0-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:
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.

Education: MANDATORY
•BA/BS in Life Sciences, Engineering, or related field or equivalent combination of education & experience.

Experience: PREFERRED
•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.

Organization/Planning: MANDATORY
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.

The sourcing period for this position will end on July 14, 2018.

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.

Requisition ID: 57605BR
State/Provinces: Clayton
Job Category: Quality

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