Process Engineer I - Printed Packaging Material

Novo Nordisk • Clayton, NC

11d • Onsite

About The Position

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.

The overall responsibility is to represent Finished Production – Packaging & assist in ensuring compliance of internal processes & the enforcement of supplier agreements according to specifications for the Novo Nordisk Production sites in North Carolina, IFP Clayton.

Requirements

• Bachelor's Degree in Engineering or related field, or equivalent combination of education & experience required
• Minimum of four (4) years of packaging, production, or production quality support experience, preferably in a GMP-regulated environment preferred.
• Previous experience in PPM manufacturing environment a plus
• Previous experience in deviation handling (DV owner) preferred
• Project Management experience preferred
• Owning process improvement initiatives preferred
• Proven experience within production environment that is highly dependent on input components required
• Proven experience within handling of nonconformities & changes in a GMP regulated industry preferred
• Strong Quality Mindset, proven detailed-oriented approach preferred
• Knowledge of specification and requirement landscape for PPM, including PPM manufacturing & QMS methods to understand and challenge supplier root cause investigation & CA/PA preferred
• Knowledge of production processes & how input components may impact quality of finished goods required
• IT knowledge & understanding a plus
• Data Analytics a plus
• Demonstrated experience in practical problem solving & process improvement methods preferred
• Knowledge of US, EU regulations & guidelines, GxP/ISO & application of GMP’s preferred
• Ability to communicate technical information clearly in writing & presentations preferred
• Challenging the status quo with innovative ideas aligned to innovation preferred
• Experience planning, organizing, managing execution, checking results, & revising work plans preferred
• Strong communication & stakeholder management skills across multiple organizational levels preferred

Nice To Haves

• Previous experience in PPM manufacturing environment a plus
• Previous experience in deviation handling (DV owner) preferred
• Project Management experience preferred
• Owning process improvement initiatives preferred
• Knowledge of specification and requirement landscape for PPM, including PPM manufacturing & QMS methods to understand and challenge supplier root cause investigation & CA/PA preferred
• IT knowledge & understanding a plus
• Data Analytics a plus

Responsibilities

• Knowledgeable in assigned process to identify opportunities for, & drive process improvements related to Printed Packaging Material (PPM)
• Identify, evaluate, & provide input on PPM related complaints coming from production
• Responsible for providing Nonconformity & Change-Request input for PPM related issues
• Site contact for Device Manufacturing Development related to PPM issues
• Perform trending & data analysis on observed improvement opportunities for PPM specifications on on-going basis
• Actively & independently drive systematic problem solving with internal & external stakeholders
• Act as Project Manager for optimization of PPM processes within IFP Clayton
• Provide input from Finished Production – Packaging for Deviations & Change Requests regarding Printed Packaging Material (PPM) to ensure GxP/ISO compliance
• Participate in quality meetings with suppliers & production lines at IFP Clayton
• Assist in performing Out of Specification (OOS) assessments & Own actions related to anchoring improvements
• Support supplier compliance monitoring & trend analysis in partnership with Business Support
• Partner with compliance manager in executing supplier evaluations
• Other accountabilities, as assigned

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level