Quality Control Validation Area Specialist I

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 approximately 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 this by rethinking our production facilities with the use of modern technology, setting the standards for the aseptic production of the future. Facilities designed today will still be a source of pride 20 years from now. FF Expansions has a global approach, where you will work with multiple sites and cultures across the world.

Responsibilities

• Plan, manage, and perform laboratory validation activities.
• Routinely review laboratory validation procedures and completed validation protocols for accuracy, completeness, and maintenance of validated state per corporate requirements.
• Serve as change control responsible for QC equipment.
• Collaborate and coordinate with IT, metrology, and other key stakeholders to ensure the right quality, cost, and timely completion of all deliverables.
• Ensure accuracy and compliance of validation and equipment records.
• Identify and handle deviations per proper appropriate procedures.
• Maintain good standing with stakeholders through engagement and positive cooperation.
• Perform and oversee change control activities for QC equipment and systems.
• Follow all safety and environmental requirements in the performance of duties.
• Other accountabilities, as assigned.

Physical Requirements

• Moves equipment and/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 require corrected vision to 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 and/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.
• Minimum of two (2) years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or related field required.
• Experience in writing and 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 and implementing equipment projects required.
• Demonstrated ability to write and present technical/scientific documents and reports preferred.
• Understanding of QC equipment/systems, end user functionality, and life-cycle management a plus.

Benefits

• Leading pay and annual performance bonus for all positions.
• 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.
• 14 weeks paid parental leave and 6 weeks paid family medical leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.
• Tuition Assistance.
• Life & Disability Insurance.
• Employee Referral Awards.