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 positionsAll employees enjoy generous paid time off including 14 paid holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition Assistance Life & Disability InsuranceEmployee 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
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.
Night Shift position: 6PM - 6:30AM; Friday - Sunday and every other Thursday
Relationships
Reports to: Manufacturing Supervisor
Essential Functions
Room Lead:
Has developed expertise through a combination of job-related training and considerable on-the-job experienceTypically acts as a lead, coordinating the work of others – but not a people managerWorks autonomously within established procedures and practicesAssist manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistanceHas expertise over area procedures and provides recommendation for improvement and changesAdvise management on proposed Corrective ActionsMust have in depth understanding and usage of Operational Excellence concepts and toolsCommunicating of goals and delegating tasks for the shift to team membersEscalates to Supervisor as expectedEnsuring batch record documentation is performed; reviewed throughout shift and turned in for review in expected timeframeCoordinating tasks with supporting groups (Quality, MS&T, Maintenance, etc)Ensuring training for team members complies for work that is being performedElectronic verification of allocated materials for processingAssists in onboarding of new employeesEquipment Lead:
Has developed expertise through a combination of job-related training and considerable on-the-job experienceTypically acts as a lead, coordinating the work of others on the filling machine – but not a people managerWorks autonomously within established procedures and practicesAssist manufacturing personnel to identify & eliminate waste, implement standard-work, and provide problem solving & solution implementation assistanceHas expertise over area procedures and provides recommendation for improvement and changesAdvise management on proposed Corrective ActionsMust have in depth understanding and usage of Operational Excellence concepts and toolsSafely operates complex equipment in accordance with cGMPsMust have in depth understanding of equipment and recommend solutionsCoordinating tasks with supporting groups (Quality, MS&T, Validation, Maintenance, etc)Support Maintenance/Engineering teams during repairs/upgradesPerform routine preventative maintenance work on equipmentAssists in onboarding of new employeesCompletes a variety of atypical assignments, as needed
Qualifications
- Education/Experience:
- High School/GED required
- Associate's degree or higher preferred
- 2 years of direct pharmaceutical manufacturing experience
- 2 years of GMP experience
Technical Requirements:Proficient in Excel, Word, and other office systemsAbility to learn and use quality, operations and/or scientific management software such as TrackWise®, ComplianceWire®, JD Edwards®, Chromatography (i.e. Unicorn®), etc.Ability to understand and apply CGMPs to everyday workDemonstrates basic understanding of the work tasks assignedExecutes procedures with high qualityBasic understanding of pharmaceutical production operationsCapable of learning unfamiliar principles or techniques with trainingContribute to deviation investigations and corrective / preventative actionsAbility to interpret data, analyze trends, and participate in solutionsParticipate in technical calls and discussions regarding investigations or other issuesApplies best practices to work activitiesBehavioral 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 necessaryAbility to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of timeAbility to cooperate with coworkers within an organized team environment or work aloneDetail oriented and well organized with ability to work effectively under high pressure with multiple deadlinesAbility to put aside personal opinions and focus on business needs, department needs or group needsLeadership Requirements (No Direct Reports):Lead by example according to Catalent's values and cultureDevelops contacts and builds relationships with peersSeeks to learn from othersTakes initiative when necessary to address changes in scope or procedural errorsBuilds trust and respect for self and departmentPhysical 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.
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-###-####. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.