Engineer, Process - Drug Substance (Bloomington, IN, US)

Biopharma Careers; United States; On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Paid time off

Health insurance

Dental insurance

Vision insurance

401(k) with company match

Parental & family leave

Tuition assistance

Life & Disability Insurance

Employee referral rewards

Job summary

Novo Nordisk is seeking an Engineer, Process - Drug Substance at our Bloomington, IN site. You will support bioprocess equipment selection, installation, and operational SOP development, while ensuring GMP compliance and cross-functional collaboration with Validation, QC, Manufacturing, and Process Development teams.

The role emphasizes troubleshooting, budget planning, and capital project oversight, with opportunities to influence site utilities and SOP improvements within a cutting-edge

Qualifications

• Bachelor's Degree and a minimum of two (2) years of relevant experience required.
• In lieu of Bachelor's Degree with two (2) years of experience, a Master's Degree in related field with zero (0) year of relevant experience is acceptable.
• In lieu of Bachelor's Degree with two (2) years of experience, a PhD/PharmD in related field with zero (0) year of relevant experience is acceptable.
• 2+ years of Project Engineering related experience

Responsibilities

• Support selection and installation of bioprocessing equipment.
• Draft SOPs for bioprocess equipment operation, maintenance, and calibration.
• Provide engineering guidance and execution on equipment projects.
• Perform hands-on activities to troubleshoot equipment problems.
• Collaborate with Validation, Quality Control, Manufacturing, Process Development, and Facilities.

Skills

Project Engineering

GMP awareness

Problem-solving

Education

Bachelor's Degree in related field

Master's Degree in related field

PhD/PharmD in related field

Job description

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.

The Position

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.

Relationships

Reports to Manager or above.

Essential Functions

• 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

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 related field of study from an accredited university required and a minimum of two (2) years of relevant experience required
• In lieu of Bachelor's Degree with two (2) years of experience, may consider a Master's Degree in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required
• In lieu of Bachelor's 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, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've 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 what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're 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.