Process Engineer I - Printed Packaging Material - SDF

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 and obesity. Being part of Novo Nordisk allows our employees to help improve the quality of life for millions of people around the world. In North Carolina, we operate three pharmaceutical manufacturing facilities responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Emerging Technologies - Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

About the Role

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

Reports to Manager.

Responsibilities

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

Physical Requirements

• Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions.
• Routinely operates and inspects manufacturing equipment using hands.
• Strap and 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 and/or hazardous materials.
• May be required to wear latex gloves.
• May perform critical job functions in extremely cold work environments depending on site.
• May position oneself within confined spaces for inspection if required of the role.
• Ability to work in loud noise environments with hearing protection.
• May be required to secure a motorized vehicle license and operate a motorized vehicle based on the role.

Qualifications

• Bachelor’s Degree in Engineering, Science, or relevant technical field of study from an accredited university required with a minimum of one (1) year of engineering or technical experience, preferably in a GMP-regulated environment.
• May consider an Associate’s Degree in Engineering, Science, or relevant technical field of study from an accredited university with a minimum of three (3) years of engineering or technical experience, preferably in a GMP-regulated environment.
• May consider High School Diploma or equivalent with a minimum of five (5) years of engineering or technical experience, preferably in a GMP-regulated environment.
• Minimum of four (4) years of packaging, production, or production quality support experience, preferably in a GMP-regulated environment.
• 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 and 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 and QMS methods to understand and challenge supplier root cause investigation and CA/PA preferred.
• Knowledge of production processes and how input components may impact quality of finished goods required.
• IT knowledge and understanding a plus.
• Data Analytics a plus.
• Demonstrated experience in practical problem-solving and process improvement methods preferred.
• Knowledge of US, EU regulations and guidelines, GxP/ISO, and application of GMPs preferred.
• Ability to communicate technical information clearly in writing and presentations preferred.
• Challenging the status quo with innovative ideas aligned to innovation preferred.
• Experience planning, organizing, managing execution, checking results, and revising work plans preferred.
• Strong communication and stakeholder management skills across multiple organizational levels preferred.

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 and 6 weeks paid family medical leave.
• Free access to Novo Nordisk-marketed pharmaceutical products.
• Tuition Assistance.
• Life and Disability Insurance.
• Employee Referral Awards.