Validation Area Specialist - FFEx - Warehouse/Intralogistics

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 12 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

Primary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.

 

Relationships

Senior Project Manager, Site Capacity & Upfit.

 

Essential Functions

• Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols
• Ownership of Change Requests (CR’s) related to project validation responsibilities
• Perform compliance & technical reviews/approvals of protocols & protocol data
• Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation
• Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes.  Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment.  Serves as a source of expertise in the group for validating new systems
• Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations
• Lead validation failure investigations & non-conformities utilizing root cause analysis techniques
• Create & modify existing validation procedures & configuration item lists (CIL’s) as required
• Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes
• Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment
• Identify process improvements before