Pharmaceutical Operator - FFEx (AP-Wash & Sterilization)

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 40,000 - 80,000; Full time

Job summary

Join a forward-thinking company focused on expanding aseptic production capabilities to serve millions of patients. This role involves assisting in the development and validation of processes for a new production facility. You'll engage in documentation, training, and maintenance protocols while ensuring compliance with safety and environmental standards. With a commitment to innovation and quality, this position offers a chance to make a significant impact in the pharmaceutical industry. If you're ready to grow your career in a supportive environment, this opportunity is for you.

Benefits

Leading pay and annual performance bonus

Generous paid time off

Health, Dental, and Vision Insurance

Guaranteed 8% 401K contribution

Family-focused benefits

Free access to medicines

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Qualifications

• Minimum two years in an FDA-regulated environment.
• Ability to interpret complex documentation.

Responsibilities

• Assist in start-up and validation of new equipment.
• Review standards to maintain aseptic areas.

Skills

Aseptic Processing

Documentation Review

Environmental Monitoring

Planning and Organizing

Computer Literacy

Education

High School Diploma or Equivalent

Job description

About the Department

You will be joining Fill & Finish Expansions (FFEx), responsible for 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 part of Product Supply, Quality & IT, employing approximately 20,000 of Novo Nordisk’s 50,000 employees globally.

FFEx is a newly established, growing area tasked with designing, planning, and building new aseptic filling capacity across Novo Nordisk to serve millions of patients. We innovate by integrating modern technology, setting standards for future aseptic production. Facilities designed today will remain relevant for decades. FFEx operates globally, collaborating across multiple sites and cultures.

What we offer you:

• Leading pay and annual performance bonus
• Generous paid time off, including 14 paid holidays
• Health, Dental, and Vision Insurance from day one
• Guaranteed 8% 401K contribution plus company match
• Family-focused benefits, including 14 weeks paid parental leave and 6 weeks paid medical leave
• Free access to Novo Nordisk medicines
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, we provide opportunities, resources, and mentorship to grow 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 operate aseptically for Formulation, Wash/Sterilization, Filling, & media preparations through documentation, start-up, and validation activities for a new production facility.

Relationships

Reports to the Manager.

Essential Functions

1. Review & author Job Instructions, SOPs, and other documents
2. Assist in start-up and validation of new equipment
3. Review standards to maintain aseptic areas & perform sanitizations & environmental monitoring
4. Support event response planning
5. Assist maintenance team with protocols for restoration of functions, predictive & preventive maintenance
6. Support SMEs in training employees, including learning systems & equipment outside of their expertise
7. Follow safety & environmental requirements
8. Other duties as assigned

Physical Requirements

Move equipment & supplies weighing up to 33 pounds, operate & inspect manufacturing equipment, strap/unstrap pallets, and work on your feet for up to 12 hours. May require corrected vision, color vision, working at heights, around hazardous materials, and in cold or loud environments. May need to operate a motorized vehicle.

Qualifications

1. High school diploma or equivalent
2. Minimum two years in an FDA-regulated environment
3. Aseptic processing experience
4. Isolator experience preferred
5. Ability to interpret complex documentation
6. Computer literacy
7. Planning, organizing, and managing skills preferred

We are committed to diversity and equal opportunity. If you need accommodations to apply, please call 1-855-411-5290.