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Operator II - Utility & RMS (2 OPENINGS for NIGHT SHIFT)

Facility:  Engineering
Location: 

Clayton, NC, US

About the Department                                                                                                                                             

At Novo Nordisk, we want to make a difference. For nearly 100 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 improve the quality of life for millions of people around the world. Working at our Diabetes Active Pharmaceutical Ingredient (DAPI) manufacturing facility, you will help meet the growing demand for our treatments. Novo Nordisk expects to double production of diabetes and obesity products over the next decade; we have recently completed construction of a 825,000 sq. ft diabetes Active Pharmaceutical Ingredient (API) plant in Clayton, NC. Our new API facility houses the fermentation, recovery and purification of GLP1 ingredients for Novo Nordisk’s innovative oral products. Here, you will work with the best manufacturing professionals in the industry. Are you ready for a life-changing career?
 

THIS ROLE IS NIGHT SHIFT (TEAM C or TEAM D)

 

Position Purpose

The purpose of the position is to operate utility and RMS process equipment to support DAPI-US production. Responsibilities include operations and maintenance of applicable equipment within the scope of the department. Other duties will include the development of SOPs, training and process improvements to support quality and financial goals for the site. Ensure establishing & maintaining positive working relationships with internal & external stakeholders and all activities are aligned with Environmental Health & Safety (EHS) program expectations.

 

Accountabilities

  • Work in a safe & environmentally responsible manner
  • Operate equipment and processes following Standard Operating Procedures for both nGMP and GMP systems
  • Prompt identification and documentation of system or operational anomalies for cause & clearance to minimize downtime and ensure a safe working environment
  • Assist in maintaining/writing standards & operational procedures for automated and manually operated systems
  • Support consistent operation, maintenance & response for all control systems (BMS, PCS, Life Safety)
  • Support stakeholders as required for successful plant operations including maintenance and optimization activities
  • Coordinate and Execute raw material movement and offload into process systems
  • Independently execute site rounds and equipment inspections to ensure efficient and compliant operations
  • Adhere to all Quality & Environmental regulations
  • Participate in systematic problem-solving efforts
  • Manage individual training plan
  • Train team members following the 4P principles
  • Responsible for routine cleaning and good house keeping for assigned areas
  • Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
  • Other duties as assigned

 

Required Qualifications

  • High school graduate or equivalent
  • Minimum 5 years of experience in regulated industry
  • Computer literacy with associated systems

 

Desired Qualifications

  • BA/BS degree or higher in related field or equivalent education & experience
  • BioWork or equivalent
  • Knowledge & experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA)
  • 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
  • Proficient in the operation and design production utility systems or raw material handling such as: purified water, process air, chemical storage & process waste systems
  • Ability to work with electronic batch records, automated process equipment, and/or DeltaV or Syncade.
  • Ability to read/review equipment documents with a basic understanding
  • Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts
  • Proven ability to check results & revise work tasks to meet 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

  • Able to move equipment and/or supplies weighing up to 50 pounds within the facility
  • Able to routinely operate & inspect manufacturing equipment using hands
  • Able to remain in a stationary position up to 100% of the time
  • Able to constantly position oneself to transfer materials within manufacturing environment
  • Able to frequently move about the building to access other personnel & operational areas
  • Able to move throughout the facility to interact with other employees in the normal office & manufacturing environment
  • Corrected vision to 20/30 and/or ability to pass vision screening assessment necessary to procure motorized vehicle license
  • Able to ascend/descend a ladder to service equipment
  • Able to work atop elevated positions at heights
  • Able to secure a motorized vehicle license & operate motorized equipment
  • Able to work around odorous and/or hazardous materials
  • Able to perform critical job functions in extremely cold work environments
  • Able to work around mechanical equipment
  • Able to work hours as needed to support production including on call, some evenings and/or weekends
  • Able to position oneself within confined spaces for inspection, repair & maintenance of equipment
  • Able to work in loud noise environments with hearing protection
  • Able to work in & around an active construction site during project phase
  • Able to travel internationally
  • Able to attain clean room gowning certification
  • Ability to work hours necessary to support production, including ability to stand on feet up to 12 hours or longer, day or night.
  • Novo Nordisk is requiring all employees to be fully vaccinated with a COVID-19 vaccine by December 8, 2021. As required by applicable law, we will consider requests for reasonable accommodation for those unable to be vaccinated.

    If you will be submitting a religious or medical exemption, your request must be received by October 20, 2021. All requests for exemptions will be evaluated on an individual basis and will require documentation regarding the specific request.

  • For Medical Exemption requests, please contact Premise Health at 919-550-2200 ext. 2248 or via email at USCLNurse@PremiseHealth.com.
  • For Religious Exemption requests, please contact AskHR by calling 855-411-5290.
  • A member of People and Organization will be in touch with you after the review of your exemption request after the deadline mentioned above.

    If you have already been fully vaccinated, Premise Health will ask for your vaccine record during your pre-employment physical. If you have yet to be vaccinated, you will receive information on how to submit your record prior to the December 8th deadline on your first day of New Hire Orientation.

 

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.

 

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

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.