Wash and Sterilization/Formulation Process Professional I

BioSpace; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

14 paid holidays

8% 401K company match

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Job summary

Novo Nordisk in Clayton, NC, seeks a Process Improvement Engineer to support operations, analyze deviations with QA, and drive Lean-based improvements. You will mentor teammates and help implement effective process changes in a regulated pharmaceutical setting.

Strong problem-solving, GMP knowledge, and ability to train others are essential for success. This role emphasizes training, compliance, and cross-functional teamwork.

Qualifications

• Bachelor’s degree in engineering, technology or related field required.
• Minimum of one year of manufacturing experience preferred, ideally in pharma.
• GMP knowledge and strong written communication are essential.
• Experience with change control and QMS systems is preferred.
• Exposure to regulatory audits is a plus.

Responsibilities

• Lead in depth deviation investigations and root cause analysis with QA.
• Drive continuous improvement using Lean tools and methods.
• Provide training on process changes to junior team members.
• Identify and implement routine to moderate process improvements.
• Collect data for periodic reviews and reporting.
• Adhere to safety and environmental requirements in duties.

Skills

Excellent written communication

GMP knowledge

Problem-solving

Adult learning methodologies

Training others

Change control knowledge

QMS knowledge

Regulatory audits exposure

Education

Bachelor's degree in engineering/technology or related field

Associate's degree with 2+ years manufacturing experience

High School Diploma with 4+ years manufacturing experience

Tools

SAP

PAS-X

Job description

About The Department

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.

About The Department

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
• 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

Support people, equipment and processes for our operations areas to meet business and regulatory requirements. Provide process solutions for routine to moderate complexity issues. Support training for junior team members.

RELATIONSHIPS

Reports to Manager.

Essential Functions

• Work with production and QA to provide in depth deviation investigations and root cause analysis
• Drive continuous improvements via Lean tools
• Provide training on process and procedure changes
• Identify and implement process needs and improvement opportunities for routine to moderate complexity issues
• Responsible for collection of data for periodic reviews and reporting
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 20% of the time (% can change on a case-by-case basis based on the role).

Qualifications

• Bachelor’s degree (engineering, technology or related field of study preferred) from an accredited university required
• May consider an Associate’s degree from an accredited university with a minimum of two (2) years of manufacturing experience required
• May consider a High School Diploma (GED) with a minimum four (4) years of manufacturing experience required
• Minimum of one (1) year of manufacturing experience preferred, preferably in a pharmaceutical manufacturing environment
• Excellent written communication skills required
• GMP knowledge required
• Basic investigation and systematic problem-solving experience required
• Manufacturing experience preferred
• General knowledge of change control and Quality Management System (QMS) systems preferred
• Relevant electronic manufacturing system experience preferred (ex: SAP, PAS-X, etc)
• Demonstrated knowledge of adult learning methodologies and ability to use multiple methods to train others preferred
• Exposure to regulatory audits/inspections a plus

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.