Metrology Area Specialist I - Solid Dose Forms

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies -Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Procure, manage & maintain traceable calibration standards for use in the site calibration system. Develop & manage calibration specifications & methods in accordance with cGMP, site/corporate procedures, policies, & business needs. Implement calibrations in SAP. Select, audit & approve external calibration service suppliers.

Relationships

Reports to the Manager, Metrology.

Essential Functions

• Ensure correct calibration standards are available
• Create, approve & manage calibration specifications & methods, in area of responsibility
• Configure SAP maintenance plans, scheduling & task lists in accordance with approved specifications
• Support equipment owners in all aspects related to instrumentation (calibration specs, problem solving, instrument selection, failure investigation)
• Support Metrology technicians in training, problem solving & improvement project
• Perform failure investigations (non-conformities) related to Metrology/Calibration process
• Drive improvements in calibration methods, standards, & specifications to fulfill customer needs
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to be on feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. Occasionally performs critical job functions in extremely cold work environment. Occasionally positions oneself within confined spaces for inspection, repair & maintenance of equipment. Ability to work in loud noise environments with hearing protection. Occasionally works in outdoor weather conditions. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

Qualifications

• Bachelor’s degree in engineering or a science related field of study from an accredited university required, or equivalent combination of education & experience
• May consider an Associate’s degree in engineering or a science related field of study from an accredited university required with seven (7) years of experience in pharmaceutical calibrations/metrology or other highly regulated industry
• May consider a High School Diploma or equivalent with nine (9) years of experience in pharmaceutical calibrations/metrology or other highly regulated industry required
• Minimum of five (5) years of experience in pharmaceutical calibrations/metrology or other highly regulated industry required
• Experience in planning maintenance &/or calibration activities preferred
• Experience investigating GMP calibration or instrument failures preferred
• Experience in preparing technical instructions/procedures preferred
• Demonstrated experience in measurement instrumentation theory & method development required
• Demonstrated experience in calibrating pharmaceutical or other highly regulated instrumentation required
• Working knowledge of cGMPs, corporate, & site level requirements & procedures preferred
• Demonstrated ability to write technical documents, instructions & reports preferred
• Demonstrated ability to present technical information to others preferred
• Working knowledge of SAP, PM & QM modules a plus
• Working knowledge of Word & Excel software applications required
• Working knowledge of handling & accounting for measurement uncertainty a plus
• Demonstrated ability to manage multiple tasks & responsibilities with competing priorities preferred

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.

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.