Packaging, Lead

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

Operate and maintain Assembly/Packaging manufacturing equipment to achieve production goals.

Relationships

Reports to: Supervisor, Packaging

Qualifications

• Education/Experience:
  • High School/GED required
  • Associate’s degree or higher preferred
  • 2 years of direct pharmaceutical manufacturing experience preferred
  • 2 years of GMP experience preferred
• Technical Requirements:
  • Proficient in Excel, Word, and other office systems
  • Ability to learn and use quality, operations and/or scientific management software such as TrackWise®, ComplianceWire®, JD Edwards®, LIMS, etc.
  • Ability to understand and apply CGMPs to everyday work
  • Demonstrates advance understanding of the work tasks assigned
  • Executes procedures with high quality
  • Basic understanding of pharmaceutical production operations
  • Capable of learning unfamiliar principles or techniques with training
  • Contribute to deviation investigations and corrective / preventative actions
  • Ability to interpret data, analyse trends, and participate in solutions
  • Applies best practices to work activities

• Behavioural Requirements:
  • 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 (No Direct Reports):
  • Lead by example according to Catalent's values and culture
  • Develops contacts and builds relationships with peers
  • Seeks to learn from others
  • Takes initiative when necessary to address changes in scope or procedural errors

Essential Functions

• Room Lead
  • Has developed expertise typically developed through a combination of job-related training and considerable on-the-job experience
  • Typically acts as a lead, coordinating the work of others – but not a people manager
  • Works autonomously within established procedures and practices
  • Assist manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance
  • Take a leadership role in the investigation of procedural deviations, SOP revisions and non-conformances, working closely with Quality Assurance counterpart’s to develop and execute robust CAPAs
  • May lead shift handover or act as a shift lead in the absence of a supervisor
  • Must have in depth understanding and usage of Operational Excellence concepts and tools
  • Assigns employees responsibilities and tasks to be perform for the day
  • Operators time management including rotations
  • Escalate behavioral or non-conformance to Supervisor
  • Advance Documentation Skills (GMP preferred)
  • Capable of working with minimal supervisor and high-level stressed environment
  • Ability to work with cross functional departments
  • Ability to identify opportunities for improvement such as 5S, waste elimination and non-value-added tasks
  • Ability to lead and perform first line operator functions
  • Additional duties may not be limited to the job description and will be up to the Manager to be added as required
  • Review all activities within the Master Batch Record (MBR) throughout the shift, at the end of shift and at the end of production to ensure effective and accurate communication of production activities is documented in accordance with standing procedures and ALCOA principles
• Equipment Lead
  • Works within defined processes and procedures or methodologies and may help determine the appropriate approach for new assignments
  • Safely operates complex equipment in accordance with cGMPs
  • General understanding of batch records and following procedures based off the steps provided in a batch record
  • Troubleshoot basic equipment and recommend solutions
  • Efficiently and safely setup and changeover various pieces of production equipment within the department
  • Escalate equipment issues in a timely manner to avoid downtime
  • Has developed expertise typically developed through a combination of job-related training and considerable on-the-job experience
  • Trains other employees on the equipment within the department
  • Able to print reports and correctly diagnose the report for accuracy according to the quantity of the finished product
  • Submit work orders for complex trouble shooting issues via maintenance request eform
  • Assists the Production Supervisor in staffing fellow Equipment Operators for successful production runs
  • Log detailed equipment issues in an event log that is issued within the batch record
  • Reviews all equipment related activities within the Master Batch Record (MBR) throughout the shift to ensure effective and accurate communication of equipment and production activities
  • Provide leadership to manufacturing and equipment personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistance
  • Sends daily shift reports to other shifts with a breakdown of production and equipment issues
  • Likely to act as an informal resource for colleagues with less experience
  • Partners with engineering and production supervisors to develop training for peers and implement improvement projects
  • Assist equipment operators and provide coaching on how to interact with equipment when required
  • Expected to fulfill and maintain designated trainer requirements as needed

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 35 pounds. Must pass annual vision test. 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.

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.