Senior Engineer, MS&T

Novo Nordisk•Bloomington, IN

6d•Onsite

About 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.

Requirements

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

Responsibilities

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