Quality Control Validation Area Specialist I

Novo Nordisk; Clayton (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

14 holidays

Health insurance

Dental insurance

Vision insurance

401K match 8%

Parental leave

Tuition assistance

Life insurance

Disability insurance

Employee referrals

Job summary

Novo Nordisk in Clayton, NC seeks a Laboratory Validation/Qualification professional to plan, manage and perform validation activities for QC equipment and instrumentation. Collaboration with IT and metrology ensures quality, cost control, and timely deliverables.

Knowledge of GMP and experience in writing validation protocols are required. This role emphasizes project leadership, cross-functional coordination, and adherence to corporate validation standards in a fast-paced pharmaceutical

Qualifications

• Bachelor’s Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university required
• Associate's Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of four (4) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
• Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
• Experience in writing & executing validation protocols preferred
• Experience in managing projects preferred
• Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus
• Working knowledge of GMPs required
• Ability to act as project manager driving & implementing equipment projects required
• Demonstrated ability to write & present technical/scientific documents & reports preferred
• Understanding of QC equipment/systems, end user functionality & life-cycle management a plus

Responsibilities

• Plan, manage & perform laboratory validation activities.
• Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements.
• Change control responsible for QC equipment.
• Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.
• Accuracy & compliance of validation & equipment records.
• Validation responsible for QC equipment & instrumentation
• Identify & handle deviations per proper procedures
• Perform & oversee change control activities for QC equipment & systems
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities, as assigned

Skills

Instrument validation

Laboratory validation

Engineering experience

Project management

Technical writing

GMP knowledge

SAP PM

SAP QM

TIMS electronic validation

Education

Bachelor's Degree in Life Sciences / Chemistry / Engineering

Associate's Degree + 4 years pharma experience

Tools

TIMS

SAP PM

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

Plan, manage & perform laboratory validation activities. Routine review of laboratory validation procedures & completed validation protocols for accuracy, completeness & maintenance of validated state per corporate requirements. Change control responsible for QC equipment. Collaboration & coordination with IT, metrology & other key stakeholders to ensure the right quality, cost & timely completion of all deliverables.

Relationships

Reports to Manager.

Essential Functions

• Accuracy & compliance of validation & equipment records
• Validation responsible for QC equipment & instrumentation
• Identify & handle deviations per proper appropriate procedures
• Maintain good standing with stakeholders through engagement & positive cooperation
• Perform & oversee change control activities for QC equipment & systems
• Follow all safety and 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. Ability to do close precision work with their hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May required corrected vision to 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.

Qualifications

• Bachelor’s Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university required
• May consider Associate's Degree in Life Sciences, Chemistry, Engineering or a relevant field of study from an accredited university with a minimum of four (4) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
• Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required
• Experience in writing & executing validation protocols preferred
• Experience in managing projects preferred
• Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus
• Working knowledge of GMPs required
• Ability to act as project manager driving & implementing equipment projects required
• Demonstrated ability to write & present technical/scientific documents & reports preferred
• Understanding of QC equipment/systems, end user functionality & life-cycle management 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.