Operator I, Formulation / Filling (Multiple Shifts) )

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

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

Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, material staging, and aseptic filling. Product in this area is filled into vials, syringes or cartridges inside sterile isolator barriers.

Relationships

Reports to Manufacturing Supervisor.

Shift: Weekday AM-6AM-6:30PM Monday-Wednesday and every other Thursday

Essential Functions

Duties For All Functional Groups

Has developed operational skills through formal training or work experience

Demonstrate mathematical skills, including the ability to perform addition, subtraction, multiplication, division, significant figures and unit conversions

Reports safety and quality concerns and recommends improvement

Works within established procedures with a moderate degree of supervision

Daily execution of required clean room sanitizations

Electronic verification of allocated materials for processing

Perform area room clearances prior to batch execution

General housekeeping items (waste collection, stocking, etc) within production areas

Executes work while following Good Documentation Practices and Aseptic Behavior

FormulationPerforming standard calculations to achieve desired weight/mixture of drug products

Aliquoting liquids and powders from one vessel to another per batch record instructions

Performing sterile filtration and integrity testing of product filters

Cleaning and sterilizing tanks with automated equipment (i.e. CIP/SIP)

FillingPerforming in-line sterile filtration and integrity testing of product filters

Set up of filling equipment which includes part installation on filling line

Run and troubleshoot complex machinery through Human Machine Interface (HMI)

Collect and deliver samples throughout execution per sampling plan

Perform unit counts post batch execution

Performing quality checks of finished units during fill processing

PrepIdentifying and retrieving applicable equipment needed for batch execution

Wash/Clean/Sterilize equipment using automated and manual process

Prepare small and large equipment assemblies

Post batch activities such as reconciliation and filter integrity testing

Material Staging (Pit Crew)

Staging/Sanitization of materials in classified areas

Coordinating deliveries of materials with Supply Chain

Electronic verification of material movements for processing

Delivering finished product to appropriate storage conditions

Qualifications

High School/GED required

No experience required, 1 or more years of experience preferred

GMP experience preferred

Technical RequirementsProficient with Microsoft Office programs, Email, Teams, etc.

Ability to learn and use quality, operations and/or scientific management software such as ComplianceWire, JD Edwards, etc.

Ability to understand and apply cGMPs to everyday work

Demonstrates basic understanding of the work tasks assigned

Executes procedures with high quality

Basic understanding of pharmaceutical laboratory and/or production operations

Capable of learning unfamiliar principles or techniques with training

Behavioral RequirementsAbility to see/hear and read/write clear English

Lead by example according to the Company's values and culture

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

Leadership RequirementsBuilds 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

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 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.

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.