Process Engineering Associate
1 week ago
About Our Organization
At Novo Nordisk, we are dedicated to enhancing the quality of life for millions globally. With over a century of leadership in diabetes care, our employees embark on transformative careers, contributing to the well-being of individuals around the world.
In North Carolina, we operate multiple pharmaceutical manufacturing sites, each responsible for distinct phases of our injectable and oral treatment supply chains. Our state-of-the-art Active Pharmaceutical Ingredients (API) facility in Clayton, NC spans 825,000 square feet and is equipped with advanced technology for the Fermentation, Recovery, and Purification processes essential for producing ingredients for our innovative oral products. At API, you will join a worldwide network of manufacturing experts who are passionate about their work.
What We Provide:
- Competitive salary and annual performance bonuses for all roles
- Generous paid time off, including 14 paid holidays
- Comprehensive Health, Dental, and Vision Insurance from day one
- Guaranteed 8% 401K contribution with additional company match options
- Family-oriented benefits, including 12 weeks of paid parental leave and 6 weeks of paid family medical leave
- Complimentary access to Novo Nordisk-marketed pharmaceutical products
- Educational Assistance programs
- Life and Disability Insurance coverage
- Employee Referral Incentives
At Novo Nordisk, you will discover opportunities, resources, and mentorship to foster your career growth. Are you prepared to unlock your potential? Join Team Novo Nordisk and contribute to what truly matters.
Position Overview
Your role will involve ensuring the successful implementation of process tracks. As a process expert, you will play a key role in project development. Your primary responsibilities will include providing input, reviewing, and approving design and requirement documents, as well as technical specifications.
Key Relationships
You will report directly to the Department Manager or Senior Manager.
Core Responsibilities
- Assist in the development of design and requirement specifications
- Ensure the quality of equipment and processes
- Support the creation of risk assessment documents for process tracks, including Requirement Risk Assessments (RRA's)
- Participate in the formulation of a project cGMP Statement
- Engage in Quality Risk Management (QRM) assessments related to process flows and contamination
- Provide input and review Process Failure Mode, Effects, and Criticality Analyses (FMECA's)
- Participate in design workshops with engineering partners
- Review Process Module Diagrams and Process Flow Diagrams
- Contribute to Process Scheduling and Capacity Calculations
- Support the maintenance of project timelines
- Ensure effective coordination and collaboration between project teams and other stakeholders
- Facilitate knowledge transfer from the project sponsor site
- Undertake additional duties as assigned
Physical Demands
The role may require moving equipment or supplies weighing up to 33 pounds within the facility. You will routinely operate and inspect manufacturing equipment, and may need to be on your feet for extended periods. Vision correction may be necessary based on specific tasks, and you may occasionally work in environments with noise or hazardous materials.
Qualifications
- A Bachelor's Degree in Science or Engineering (preferably Mechanical, Electrical, Chemical, or Industrial) or equivalent experience in a GMP environment for over five years is required
- At least one year of relevant engineering experience in Manufacturing, Design, Maintenance, or Process Improvement is preferred
- Familiarity with Instrument & Electrical, Mechanical, Control/SCADA/PLCs, Process Improvement Methodologies, and Root Cause Analysis (RCA) is advantageous
- Proven skills in planning, organization, and execution of maintenance activities, with the ability to adapt work plans based on complex problem resolution is a plus
We are committed to an inclusive recruitment process and equal opportunity for all applicants.
At Novo Nordisk, we strive not only to be the best company in the world but also the best company for the world. This vision is achievable only with talented employees who bring diverse perspectives, backgrounds, and cultures. We are dedicated to fostering an inclusive culture that celebrates the diversity of our workforce, the patients we serve, and the communities we engage with. Together, we are making a difference.
Novo Nordisk is an equal opportunity employer. Qualified candidates will be considered for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by applicable laws.
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