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:

1. Leading pay and annual performance bonus for all positions
2. All employees enjoy generous paid time off including 14 paid holidays
3. Health Insurance, Dental Insurance, Vision Insurance – effective day one
4. Guaranteed 8% 401K contribution plus individual company match option
5. Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
6. Free access to Novo Nordisk-marketed pharmaceutical products
7. Tuition Assistance
8. Life & Disability Insurance
9. Employee Referral Awards

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

The Room Lead acts as the technical expert on the manufacturing floor, ensuring efficient operations and timely execution of tasks. Drive continuous improvement, support team training, and tackle real-time challenges to uphold our standards of excellence.

Schedule: Day shift 3/2/2 6am-6:30pm

Relationships

Reports to Manufacturing Supervisor.

Essential Functions

• Room Lead – All areas
• The Room Lead serves as the technical expert of the area-specific process and equipment as it pertains to operations. The Room Lead acts as the primary level of floor leadership and is responsible for the timely execution and accuracy of the work of the team
• Serves as technical expert for all aspects of pertinent area
• Acts as technical and functional lead for all processing on manufacturing floor
• Leads manufacturing execution to resolve on-the floor challenges in real-time
• Identifies areas of concern/development for members of the team. Strategically assigns duties as appropriate
• Works with Supply Chain representation regarding material usage, allocation, storage, and deficiencies
• May lead shift handover or act as a shift lead in the absence of a supervisor
• Serves as the Manufacturing representative on internal and external project team meetings providing technical and functional guidance and rationale
• Supports training for new processes and procedures as it relates to new and existing customer programs
• Assists manufacturing execution to resolve on-the floor challenges in real-time. Serves as the manufacturing partner for supporting client Person in Plant (PIP) visits
• Assists cross functional teams to drive complex investigation closure, root cause analysis and effective Corrective and Preventive Action (CAPA) implementation
• Providing executional feedback to PD and MS&T to drive revision of MBR's and continuous improvement
• Independently monitors and acts on systemic process trends across manufacturing operations including material defects (e.g., non-conforming materials) and equipment performance (e.g., downtime / un-scheduled maintenance)
• Authors complex Standard Operating Procedures (SOPs) for new processes, systems, or technologies introduced into manufacturing
• Reviews and approves Standard Operating Procedures (SOPs), Work Instructions (WI’s), Department Documents, risk assessments and equipment validation documentation (e.g., User Requirement Specification (URS), Installation Qualification (IQ), Equipment Qualification Reports (EQR)) for Manufacturing operations
• Drives strategic continuous improvement (CI) programs to optimize systems and processes within Manufacturing operations
• Supports Facilities and Engineering with planned and un-planned maintenance scheduling and completion
• 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 20 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 Conditioned controlled. Ability to operate within a clean room environment as needed.

Qualifications

• High School/GED required
• Associate’s degree or higher preferred
• 2 years of direct pharmaceutical manufacturing experience required
• 2 years of GMP experience required
• Technical Requirements
• Proficient with Microsoft Office programs, Email, Teams, etc.
• • Ability to learn and use quality, operations and/or scientific management software such as ComplianceWire®, JD Edwards®, MES®, etc.
  • Ability to understand and apply cGMPs to everyday work
  • Demonstrates basic understanding of the work tasks assigned
  • Executes procedures with high quality and attention to detail
  • Basic understanding of pharmaceutical laboratory and/or production operations
  • Capable of learning unfamiliar principles or techniques with training

• Behavioral Requirements
  • Ability to see and hear and read and write clear English
  • Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary
  • Ability to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
  • Ability to cooperate with coworkers within an organized team environment or work alone
  • Detail oriented and well organized with ability to work effectively under high pressure with multiple deadlines
  • Ability to put aside personal opinions and focus on business needs, department needs or group needs
  • Ability to transfer knowledge to others via training or mentoring
  • Demonstrated ability to guide others thorough communication and learning
  • Ability to make decisions which have impact on immediate work unit
  • Ability to make decisions which have moderate impact on immediate work unit
• Leadership Requirements (if applicable)
  • Capable of leading novel/advanced area-specific processing tasks
  • Trains junior team members in novel/advanced biomanufacturing processing activities
  • Leads by example according to the Company's values and culture
  • Builds on contacts and relationships with peers
  • Takes initiative for personal and professional development
  • Takes initiative when necessary to address changes in scope and procedural errors
  • Builds trust and respect for self and department

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

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.