Senior Engineer, MS&T

BioSpace; Bloomington (IN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Leading pay and annual bonus

14 holidays

Health insurance

Dental insurance

Vision insurance

401K with company match

Parental leave

tuition assistance

Life & disability insurance

Employee referral awards

Access to Novo Nordisk products

Job summary

Novo Nordisk in Bloomington, IN is seeking a manufacturing science and technology (MS&T) professional to lead technology transfer, process optimization and lifecycle management of biomanufacturing operations. You will drive cross-functional collaboration to ensure compliant, reliable production and on-time delivery aligned with quality standards.

As SME, you will mentor colleagues, review data, author critical docs, and support risk assessments while advancing site-wide continuous improvement

Qualifications

• Bachelor's Degree in related field from an accredited university.
• Master's Degree with minimum 2 years of relevant experience.
• Doctorate Degree with no minimum experience required.
• We commit to an inclusive recruitment process and equality of opportunity for all applicants.

Responsibilities

• Serve as SME for Drug Substance operations (e.g., bioreactor processes, chromatography, TFF).
• Review GMP process data and create process flow diagrams from descriptions.
• Evaluate equipment and process improvements and document impacts.
• Review daily GMP data to monitor process performance.
• Author and approve batch records, protocols, BOMs, sample plans and SOPs.
• Review validation documents for accuracy and thoroughness.
• Lead risk assessments, deviations, CAPAs and root-cause analysis.
• Mentor and develop coworkers, including Co-ops/interns.
• Collaborate across departments to transfer and maintain processes.

Skills

GMP knowledge

Process transfer

Cross-functional teamwork

Technical leadership

Documentation skills

Education

Bachelor's Degree in related field

Master's Degree in related field

Doctorate Degree 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.

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 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 Position

Provide technical expertise and leadership to support technology transfer, process optimization and lifecycle management of manufacturing processes. Partner with cross-functional teams to ensure reliable, compliant and efficient operations while driving continuous improvement, process robustness and successful product delivery in alignment with Novo Nordisk's strategic objectives and quality standards.

Relationships

Reports to Manager or above.

Essential Functions

• Perform as a subject matter expert (SME) for a Drug Substance operation (e.g., production bioreactor processes, chromatography, tangential flow filtration, etc.)
• Utilize Process Development and client provided process data to review proposed GMP scale process descriptions. Create process flow diagrams from process descriptions
• Perform responsibilities associated with the evaluation, alignment and recommendation of equipment and process improvements
• Review daily processing data from GMP manufacturing to monitor process performance
• Authors and approves technical documents, such as batch records, protocols, bills of materials, sample plans, manufacturing campaign reports, operating procedures, etc
• Review technical and validation documents for accuracy and thoroughness
• Perform assessments on material changes as disclosed by suppliers
• Train others on manufacturing techniques and science/engineering principles
• Participate in client meetings offering technical support and act as the lead representative for MS&T
• Work cross functionally with Process Development, Manufacturing, Engineering, Automation, Quality Assurance, Quality Control, Supply Chain, Project Management, Validation, Facilities and other departments to effectively transfer and maintain processes in the facility
• Participate in and support strategic alignment across Biologics sites and the Bloomington site
• Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing
• Lead and/or support the compilation of process data, including communicating project status, trend identification and delivering internal or client presentations
• Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency and competitiveness within the market
• Support the building of business case(s) for process improvement projects
• Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls and CAPAs including determination of product or process impact, root-cause analysis and corrective action identification
• Responsible for motivating, coaching and developing coworkers as a subject matter expert
• Act as a mentor to lower-level team members and Co-ops/interns
• Perform other responsibilities to support group, site and network-based initiatives, as required
• 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 10 pounds and occasional lifting and/or moving up to 50 pounds. Must be able to work in a cleanroom environment, including being able to don cleanroom gowning, for up to 4 hours continuously. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned 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.

Qualifications

• Bachelor's Degree in related field of study from an accredited university required and a minimum of four (4) years of relevant experience required
• In lieu of Bachelor's Degree with four (4) years of experience, may consider a Master's Degree in related field of study from an accredited university with a minimum of two (2) years of relevant experience required
• In lieu of Bachelor's Degree with four (4) years of experience, may consider a Doctorate Degree in related field of study from an accredited university with a minimum of zero (0) year of relevant experience required
• 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.

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.