Validation Area Specialist - Utilities Systems

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.

 

In Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. 


Our Clayton, NC Injectable Finished Products (IFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at IFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging.

 

At IFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility.

 

Join Team Novo Nordisk and help us make what matters.

 

Position Purpose

Plan, manage & perform Black Utilities, Clean Utilities and Building Management System (BMS) Science and Risk-Based validation (SRBV) activities. Handle complex or cross functional validation projects. Close collaboration with Facilities and BMS Engineering personnel to support commissioning/validation verifications and other quality compliance needs related to the utilities and BMS systems. Collaboration with production, production support groups & other stakeholders to ensure completion of deliverables.

 

Accountabilities

  • Display high level of proficiency in utility system validation & maintenance
  • Accuracy & compliance of validation & system records
  • Identify & handle major deviations
  • Perform & train others in change control activities for Utility and BMS systems
  • Accurately & legibly records all activities in appropriate documentation
  • Reviews documentation for accuracy & completeness
  • Leads & supports cross-functional investigations & participates in systematic problems solving
  • Supports the Engineers with audit & inspection preparation and execution
  • Provides key input to developing department plans & executes work according to the schedule
  • Evaluates Utility and BMS system performance & responds to potential issues
  • Contributes to process confirmations
  • Maintains training qualifications on time
  • Supports training others as required
  • Other accountabilities, as assigned

 

Required Qualifications

  • BS/BA Degree in Engineering, or related field, or equivalent combination of work experience/education
  • Minimum of five (5) years of facility and utility experience in the pharmaceutical industry
  • Demonstrated knowledge of the Utility and BMS systems
  • Demonstrated ability to lead cross functional equipment/systems related projects with regards to SRBV and compliance
  • Working knowledge of GMPs
  • Demonstrated ability to write & present technical/scientific documentation & reports
  • High attention to detail
  • Excellent customer service skills
  • Demonstrates a systematic approach to problem solving & troubleshooting

 

Desired Qualifications

  • Working knowledge of SRBV process
  • Experience with BMS, black and clean utilities
  • Familiarity with SAP PM module
  • Demonstrates a high level of organization in task management, as well as logical planning for task execution & follow-up
  • Documents problems thoroughly & accurately & brings them rapidly to solution

 

Physical & Other Requirements

  • Ability to work in & around an active construction site during project phase
  • Ability to lift up to 33 lbs. with assistance
  • Ability to work in confined spaces, near operating equipment & with hazardous materials
  • Ability to work hours necessary to support department needs
  • Ability to travel internationally

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. 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.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.