Pharmaceutical Operator - FFEx AP

Novo Nordisk A/S; Clayton (NC); On-site; USD 48,000 - 72,000; Full time

Benefits offered by this job

Annual bonus

14 paid holidays

Insurance (health/dental/vision)

401k match

Parental leave

Product access

Life & disability insurance

Job summary

Novo Nordisk A/S in Clayton, NC seeks a hands-on production specialist to assist in aseptically operating Formulation, Wash/Sterilization, Filling and media preparations through documentation, startup and validation activities for a new production facility.

You will review job instructions and SOPs, support start-up and validation of new equipment, ensure aseptic conditions and environmental monitoring, and collaborate with SMEs while following safety and environmental requirements.

Qualifications

• Minimum two (2) years of experience in an FDA regulated environment.
• Aseptic processing experience is required.
• Isolator experience is preferred.

Responsibilities

• Review and author Job Instructions, SOPs and other documents.
• Assist in the start-up and validation of new equipment.
• Review standards to maintain aseptic areas and perform sanitizations and environmental monitoring.
• Assist maintenance in developing protocols for restoration of lost function, predictive and preventative maintenance.
• Support SMEs in training process of fellow employees in areas of expertise, including learning systems and equipment outside expert area.
• Follow all safety and environmental requirements in the performance of duties.
• Other duties as assigned.

Skills

Aseptic processing

Isolator experience

Education

High school diploma or equivalent

Job description

Select how often (in days) to receive an alert: Create Alert

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

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

Life & Disability Insurance

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

Assist in developing the structure to aseptically operate Formulation, Wash/Sterilization, Filling & media preparations through documentation, start-up and validation activities for a new production facility.

Relationships

Reports to Manager.

Essential Functions

• Review & author Job Instructions, SOP’s & other documents
• Assist in the start-up and validation of new equipment
• Review standards to maintain aseptic areas & perform sanitizations & environmental monitoring
• Assist maintenance team in the development of protocols for restoration of lost function, predictive & preventative maintenance
• Support Subject Matter Experts (SMEs) in the training process of fellow employees in areas of expertise, to include learning systems & equipment outside of area of expertise
• Follow all safety & environmental requirements in the performance of duties
• Other duties 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. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require colour 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. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

Qualifications

• High school diploma or equivalent required
• Minimum two (2) years of experience in an FDA regulated environment required
• Aseptic processing experience required
• Isolator experience preferred
• Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required
• Expertise in planning/organizing, managing execution, checking results & revising work plan preferred

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

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.