Job Description

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:

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 Secondary Manufacturing department is responsible for the execution of clinical and commercial manufacturing in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, complex and bulk packaging. Further, manufacturing operations is tasked to utilize continuous improvement methodologies to realize process optimization, efficiency gains, and waste reduction to maximize capacity outputs.

The department is comprised of four distinct, but integrated, channels. Inspection, Packaging, Label Control, and Pit Crew. The Inspection and Packaging teams execute batch production processes in a cGMP environment, focusing on ‘right first time’ and on-time delivery. The Label Control team is responsible for receiving ready to execute batch records, kitting, and control of printed materials. The Pit Crew team is responsible for storage, movement, and staging of material and product.

The Position

Relationships

Reports to: Supervisor, Inspection/Packaging

Essential Functions

Applies to Inspection and Packaging:

• Entry-level position with little or no prior relevant training or work experience
• Work is prescribed and completed with close supervision
• Duties are clearly defined, and methods and tasks are described in detail
• Safely operates basic equipment
• Supports cleaning and organizational efforts, including maintaining visual factory
• Required to read, understand, and follow GMP documents
• Participates in area continuous improvement activities
• Reports safety, quality concerns, and recommends improvements
• Demonstrates mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions
• Accurately count product via product count procedures
• Must be able to effectively palletize product and material per written specification

Packaging

• Perform basic packaging activities by constructing secondary and tertiary containers for finished packaging products
• Must be able to stand for a 12-hour shift
• Must be able to perform manual packaging and labeling activities within complex packaging operations

Label Control

• Works autonomously OR with limited supervision within established procedures
• Required to read, understand, follow, and review GMP documents
• Demonstrates mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and conversions
• Collaborates and communicates with support teams
• Utilize the assigned logbook to document workstation line clearances
• Ensures batch readiness by gathering materials and documents required for such activities
• High attention to detail due to criticality of labeling process
• Verification and inspection of printed labels
• Gather and Issue pre-printed material component
• Perform reconciliation/destruction and return of printed materials

Physical Requirements

Frequent sitting up to 12 hours for inspection or packaging, standing, walking, repetitive motion, 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 35 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. Must meet vision requirements.

Qualifications

• Education/Experience:
  • High School Diploma/GED required
  • 0-2 years relevant experience
  • GMP experience preferred
• Technical Requirements:
  • Proficient with Microsoft Office programs, Email, Teams, etc.
  • Ability to learn and use quality and operations software, including ERP system J.D. Edwards® and ComplianceWire®
  • Ability to understand and apply cGMPs and GDP to everyday work
  • Demonstrates basic understanding of the work tasks assigned
  • Executes procedures with high quality
  • Basic understanding of production operation
  • 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 (if applicable):
  • 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.

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