Associate Validation Engineer - VA

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 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

Responsible perform validation activities such as DQ, IQ, OQ, PQ and Requalification. Responsible for ensuring that the validated state of the facility, utilities, systems, and equipment are maintained.

 

***Please note we are open to hiring at more senior level commensurate with experience***

 

Relationships

Reports to Sr. Manager

 

Essential Functions

• Perform temperature mapping of systems in all process conditions (ambient, ultra-cold, etc.) as well as perform simple troubleshooting related to temperature mapping and controlled chambers
• Support leadership in performing equipment installation qualification, operational qualification, performance qualification and requalification in accordance with validation procedures
• Responsible for generating protocols, executing validations, analyzing data, generating reports, identifying validation deviations, resolving validation deviations with support from Sr Project Manager, and engagingin investigations to identify root causes and defining corrective/preventative actions
• Assist with validation documentation such as URS, risk assessments, design reviews, and reports when necessary
• Maintain training programs for validation contractors with support from SME as well as deploy test equipment training to equipment users
• Maintain system evaluations to ensure systems are staying within the validated state
• Maintain validation and process engineering test equipment within computerized maintenance system and ensure test equipment is calibrated timely and always readily available
• Work on cross-functional teams with Validation, Engineering, Manufacturing, Project Management, Quality Control, Facilities, and Quality Assurance
• Follow all safety & 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. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 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 &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold wo