Engineer, Process Drug Substance
Bloomington, IN - USA
Job Summary
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 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 including14 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.
- Support selection and installation of bioprocessing equipment
- Proactively and effectively partner with the commissioning/validation team including operational protocol development to implement compliance with FDA GMP requirements
- Draft SOPs for bioprocess equipment operation maintenance and calibration
- Identify improvements and efficiencies of preventative maintenance
- Provide engineering guidance and execution on equipment projects
- Perform hands-on activities as needed to help troubleshoot equipment problems
- Evaluate future capital bioprocess equipment projects
- Maintain compliance in accordance with quality management system
- Guide the specification and selection of bioprocessing equipment to support process needs
- Draft review execute and approve protocols and reports related to bioprocess equipment Validation
- Act as primary Subject Matter Expert (SME) for bioprocessing equipment
- Review and approve changes to bioprocessing equipment through the change control program to assess impact on validated systems
- Assist in responding to customer/regulatory audit observations and corrective actions as it pertains to bioprocessing equipment
- Identify and implement improvement opportunities for established production systems
- Collaborate significantly with cross functional groups including Validation Quality Control Manufacturing Process Development and Facilities
- Provide technical assistance and training for personnel
- File and maintain controlled documents
- Complete knowledge of varied aspects or a single specialized aspect of a discipline and some knowledge of principles and concepts in other disciplines
- Apply technical and functional knowledge to conduct experiments/research in assigned area
- May act as a technical resource within own work group/project team
- Work independently to solve problems of moderate scope
- Actively participate and suggest solutions to problems
- Follow all safety and environmental requirements in the performance of duties
- Other duties as assigned
- Bachelors Degree in related field of study from an accredited university required and a minimum of two (2) years of relevant experience required
- In lieu of Bachelors Degree with two (2) years of experience may consider a Masters Degree in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required
- In lieu of Bachelors Degree with two (2) years of experience may consider a PhD/PharmD in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required
- 2 years of Project Engineering related experience
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and defeating diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.
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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Required Experience:
IC
About Company
You will be part of the Gulf Cluster sales team based in Qatar. You will report to the Country Sales Manager. The local team consists of approx 10 employees, and has highly-engaged and experienced members that are looking for a new teammember.