Process Engineer I - Printed Packaging Material - SDF

Novo Nordisk•Durham, NC

9d•Onsite

About The Position

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. The 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.

Requirements

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 required, 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 required, 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 required, 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 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
Knowledge of production processes & how input components may impact quality of finished goods required
Ability to communicate technical information clearly in writing & presentations 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
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
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
Challenging the status quo with innovative ideas aligned to innovation preferred
Experience planning, organizing, managing execution, checking results, & revising work plans preferred

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 issues related to PPM
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
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
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 manager in executing supplier evaluations
Other accountabilities, as assigned