Operator II, Form / Fill - Weekend Days (Multiple Roles)

BioSpace; Bloomington (IN); On-site; USD 40,000 - 55,000; Full time

Job summary

A leading company in the pharmaceutical sector seeks an Operator II for Form / Fill shifts on weekends. You will be responsible for sterile product preparation, operation of filling equipment, and ensuring quality throughout the process. Applicants should have relevant experience and a strong attention to detail in a cleanroom environment. Join a team dedicated to improving patients' lives while enjoying competitive benefits and opportunities for professional development.

Benefits

Leading pay and annual performance bonus

14 paid holidays

Health, dental, and vision insurance

401K contribution plus match option

Paid parental and family medical leave

Tuition assistance

Life and disability insurance

Employee referral awards

Qualifications

• 1-2 years relevant experience required.
• 2 years GMP experience preferred.
• Ability to understand and apply cGMPs.

Responsibilities

• Prepare and formulate sterile pharmaceuticals in a cleanroom environment.
• Perform calculations for drug product mixture.
• Operate filling machines and troubleshoot equipment.

Skills

Mathematical skills

Communication

Detail oriented

Education

High School/GED

Associate degree

Tools

Microsoft Office

ComplianceWire

JD Edwards

Job description

Operator II, Form / Fill - Weekend Days (Multiple Roles)

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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.

About The Department
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 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.

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.

Weekend Day Shift position: 6AM - 6:30PM; Friday - Sunday and every other Thursday

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
Participates in and/or provides ideas for Continuous Improvement/Operational Excellence projects
Reports safety and quality concerns and recommends improvement
Works within established procedures with a moderate degree of supervision
Actively promotes and demonstrates good communication and escalation
Provides mentorship for onboarding employees
Troubleshoot and provide recommendations to resolve basic equipment/process related issues
Can provide technical descriptions of processes for investigations
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)
Able to teach others how to perform formulation processes
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
Able to teach others how to perform filling processes
Trained/Qualified to operate filling machines

Qualifications
High School/GED required
Associate degree preferred
1-2 years relevant experience
2 years 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 the Company'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): Leads by example according to the Company's values and culture
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
Expected to fulfill and maintain designated trainer requirements as needed
Promotes compliance by providing respectful & constructive peer-to-peer feedback

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.

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.