Operator I, Form/ Fill - Weekend PM
Operator I, Form/ Fill - Weekend PM
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Salary Not Disclosed
1 Vacancy
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.
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 including14 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: Supervisor Form/Fill
Shift: Weekend PM Shift Friday-Sunday 6:00pm-6:30am & every other Thursday. Schedule for SL3
Relationships
Reports to Manufacturing Supervisor.
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
oPerforming standard calculations to achieve desired weight/mixture of drug products
oAliquoting liquids and powders from one vessel to another per batch record instructions
oPerforming sterile filtration and integrity testing of product filters
oCleaning and sterilizing tanks with automated equipment (i.e. CIP/SIP)
Filling
oPerforming in-line sterile filtration and integrity testing of product filters
oSet up of filling equipment which includes part installation on filling line
oRun and troubleshoot complex machinery through Human Machine Interface (HMI)
oCollect and deliver samples throughout execution per sampling plan
oPerform unit counts post batch execution
oPerforming quality checks of finished units during fill processing
Prep
oIdentifying and retrieving applicable equipment needed for batch execution
oWash/Clean/Sterilize equipment using automated and manual process
oPrepare small and large equipment assemblies
oPost batch activities such as reconciliation and filter integrity testing
oMaterial Staging (Pit Crew)
oStaging/Sanitization of materials in classified areas
oCoordinating deliveries of materials with Supply Chain
oElectronic verification of material movements for processing
oDelivering 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
- High School/GED required
- No experience required 1 or more years of exprience preferred
- GMP experience preferred
Technical Requirements
oProficient with Microsoft Office programs Email Teams etc.
oAbility to learn and use quality operations and/or scientific management software such as ComplianceWire JD Edwards etc.
oAbility to understand and apply cGMPs to everyday work
oDemonstrates basic understanding of the work tasks assigned
oExecutes procedures with high quality
oBasic understanding of pharmaceutical laboratory and/or production operations
oCapable of learning unfamiliar principles or techniques with training
Behavioral Requirements
oAbility to see/hear and read/write clear English
oLead by example according to the Companys values and culture
oAbility 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
oAbility to manage time effectively to complete assignments in expected time frame and independently seek out additional work when tasks are completed ahead of time
oAbility to cooperate with coworkers within an organized team environment or work alone
oDetail oriented and well organized with ability to work effectively under high pressure with multiple deadlines
oAbility to put aside personal opinions and focus on business needs department needs or group needs
Leadership Requirements
oBuilds on contacts and relationships with peers
oTakes initiative for personal and professional development
oTakes initiative when necessary to address changes in scope and procedural errors
oBuilds 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 were 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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Employment Type
Full Time
