Operator II, Formulation / Filling

BioSpace; Bloomington (IN); On-site; USD 35,000 - 55,000; Full time

Benefits offered by this job

Leading pay and annual performance bonus

Generous paid time off including 14 paid holidays

Health insurance, dental insurance, vision insurance

401K contribution and company match

Family focused benefits including paid parental leave

Tuition assistance

Job summary

A pharmaceutical company is looking for an Operator II, Formulation / Filling for their Bloomington, Indiana site. This role involves sterile pharmaceutical manufacturing, where you'll perform essential functions such as formulation and filling. Candidates should have a High School or GED diploma, with some experience in GMP preferable. The position offers generous benefits, including health insurance and paid time off.

Qualifications

• 1-2 years relevant experience preferred.
• 2 years GMP experience preferred.
• Capable of learning unfamiliar principles or techniques with training.

Responsibilities

• Execute procedures with high quality.
• Perform area room clearances prior to batch execution.
• Troubleshoot and provide recommendations to resolve basic equipment/process related issues.

Skills

Mathematical skills

Good documentation practices

Problem-solving skills

Attention to detail

Education

High School/GED

Associate degree

Tools

Microsoft Office

ComplianceWire

Job description

Operator II, Formulation / Filling Weekday PM

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Operator II, Formulation / Filling Weekday PM

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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

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 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.

Relationships

Reports to: Supervisor, Form / Fill

Weekday Night Shift position: 6:00PM - 6:30AM; Monday-Wednesday and 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
• 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
• Prep
• Identifying and retrieving applicable equipment needed for batch execution
• Wash/Clean/Sterilize equipment using automated and manual process
• Prepare small and large equipment assemblies
• Post batch activities such as reconciliation and filter integrity testing
• Ability to recognize and escalate damage of equipment
• Able to teach others how to perform preparation processes
• Material Staging (Pit Crew)
• Staging/Sanitization of materials in classified areas
• Coordinating deliveries of materials with Supply Chain
• Electronic verification of material movements for processing
• Delivering 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
• Associate degree preferred
• 1-2 years relevant experience preferred
• 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
  
  
  

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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• Seniority level

  Entry level

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