Engineer, Inspection/Packaging
Bloomington, IN, US
About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
Our Bloomington, Indiana site is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility where talented teams work with innovators to help develop, manufacture and supply products to patients around 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 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
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
The role is responsible for overseeing and optimizing manufacturing processes related to the inspection and packaging of drug product. This position will support ongoing activities by assisting in troubleshooting process problems and identifying improvements in operations to minimize interruptions, maximize utilization, and supporting new and ongoing projects.
Relationships
Reports to Manager, Manufacturing
Essential Functions
- Provide process engineering support to optimize manufacturing processes within Inspection & Packaging working cross-functionally with support groups including Validation, Quality Assurance, Engineering, and Manufacturing Science & Technology
- Identifies improvement opportunities and drives activities to develop and implement solutions.
- Applies problem-solving techniques to resolve more complex assignments
- Perform process risk assessments to assess impact of proposed improvements
- Participating in commissioning and qualification activities, including IQ/OQ/PQ, for new equipment
- Acts as a technical resource within own work group/project team
- Lead investigations into process deviations, identify root causes, and implement corrective and preventive actions
- Participate in technology transfer activities to ensure smooth transfer of processes from development (PPQ) to manufacturing
- Support selection and installation of manufacturing equipment
- Provide technical assistance and training for manufacturing personnel
- Assist in responding to customer/regulatory audit observations and corrective actions
- Perform troubleshooting as it relates to assigned job duties
Physical Requirements
Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be heating ventilation and air condition controlled. Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning. May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others.
Qualifications
- Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline with 2-5 years of relevant experience, preferred
- Associate’s Degree with 5+ years of relevant experience
- PE / Registered Engineer in training, preferred
- 1+ years within the pharmaceutical or biotechnology industry with a focus on sterile biologics manufacturing, inspection and/or packaging
- Automated inspection experience, preferred
- Must be able to read and understand English-written job instructions and safety requirements
- Ability to use Excel, Word, and other office systems
- Understanding of cGMP regulations, FDA guidelines, and industry standards related to inspection and packaging
- Flexibility to adapt to changing priorities and deadlines in a fast-paced manufacturing environment
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration 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 local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.