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. As a part of Novo Nordisk, Catalent, Indiana LLC. in Bloomington, Indiana, 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.
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. The sterile barrier isolator provides a physical barrier between the manufacturing equipment and the personnel controlling the machine. The Drug Product Primary Manufacturing area is a cleanroom environment. Personnel working in this area are required to wear scrubs and/or coveralls, gloves, hairnet, safety glasses, and steel toed shoes.
The Position
Shift: Weekend AM Shift (4/3 Schedule)Relationships Reports to: Supervisor Form / Fill 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
Formulation –
Performing 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)
Filling –
Performing 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
Prep –
Identifying 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
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.
Qualifications
Education/Experience:
High School/GED Required
0-2 years of experience
GMP experience preferred
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®, 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 Requirements:
Ability to see/hear and read/write clear English
Lead by example according to Catalent'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 Requirements:
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.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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.
