QC Validation Area Specialist - Computer Software Systems

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

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 & performing laboratory validation activities on computer software systems.  This role will also be responsible for troubleshooting initial issues with laboratory software systems.  Conduct systems audits.  Responsible for IQ/OQ/PQ, installation, operational, and performance qualifications.  Review  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

Manager.

Essential Functions

• Ensure accuracy & compliance of validation & equipment records
• Responsible for validation of 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
• Support systematic problem solving related to equipment qualification
• Reviews documentation for accuracy & completeness
• Contribute to process confirmations
• Maintain training qualifications on time
• Follow all safety and 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. 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 recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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.