Engineer, Process - Drug Substance

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.

• 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

The Engineer, Process - Drug Substance, will support ongoing activities by assisting in troubleshooting mechanical problems, identifying improvements in utilities to minimize interruptions (down time) and reduce energy usage/cost, and supporting new and ongoing projects. This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight. This position will assist in identifying, tracking, forecasting, and implementing capital expenditure projects by working with site leadership and departmental end users to identify the correct project parameters and utility requirements.

The Engineer may establish new Standard Operating Procedures (SOPs) and/or recommend changes to current SOPs based on facility needs. This person will work on complex facility‑related problems requiring in‑depth data analysis to determine appropriate action. The Engineer is expected to have extensive ongoing communication with employees and cross‑functional group managers/departments on facility‑related issues.

Reports to Manager or above.

• 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…