Operator II, Formulation / Filling

Novo Nordisk • Bloomington, IN

114d

About The Position

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 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.

Requirements

• High School/GED required
• Associate degree preferred
• 1 year of relevant experience
• 2 years GMP experience preferred
• 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

Responsibilities

• 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
• 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
• Performing in-line sterile filtration and integrity testing of product filters
• Set up of filling equipment which includes part installation on filling line
• 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
• 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
• 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

Benefits

• 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

What This Job Offers

• Industry: Chemical Manufacturing
• Education Level: High school or GED