Specialist , Formulation​/Filling

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 life-changing careers, and 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:

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.

The Position

In general, this position provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner.

Relationships

Reports to:

Manager, Form/Fill

Essential Functions

• Provide direct technical support for production processes and implementation of improvements
• Ownership of Corrective Actions, Change Management, GMP document revision, review and approval
• Participate and conduct continuous improvement process changes
• Minimal interaction with Client and Regulatory Auditors
• Has developed proficiency in a range of processes or procedures through job-related training and considerable on-the-job experience
• Continuous improvement participation
• Able to identify areas of opportunities within the production processes and formulate solutions
• Completes a variety of atypical assignments, as needed
• Works within defined processes and procedures or methodologies and may help determine the appropriate approach for new assignments
• Completes work with a limited degree of supervision
• Write and revise SOP’s and WI’s
• Likely to act as an informal resource for colleagues with less experience
• Actively participates, suggests solutions to problems, and drives to timelines
• Ensure documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities
• Create and assist in implementation of Corrective and Preventative Actions (CAPAs)

Primary –

• Has developed advanced technical knowledge in a range of processes or procedures through job-related training and considerable on-the-job experience

• Completes a variety of atypical assignments, as needed
• Completes work with limited supervision
• Subject matter expert for processes and procedures within primary manufacturing
• Proposes process improvements related to equipment and processes
• Collaborates with Production Supervisors, Room Leads, and QA floor support to solve issues real time
• Provides technical knowledge of machine setup, troubleshooting, and maintaining overall efficiency
• Develops training strategies for Primary Operations
• Proficient in coaching and training floor operations in all aspects of primary manufacturing
• Review and approve documents in Electronic Data Management System (EDMS)
• Revise and route documents through EDMS
• Executes other duties as assigned

Secondary –

• Equivalent technical expertise of process and equipment with that of Senior Manufacturing Associate.

• Review and approve documents in EDMS
• Revise department documents, and route through EDMS
• Provides technical and floor support when required, and able to assist in basic troubleshooting of process and…