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Operator Iii, Formulation / Filling

3 years
Not Disclosed
10 Sept. 11, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Drug Product Primary Manufacturing Associate

Location: Bloomington, Indiana, United States
Job Category: Manufacturing


About Novo Nordisk

At Novo Nordisk, we have been leading the way in diabetes care for over 100 years. Joining our team gives employees the opportunity to improve the quality of life for millions of people worldwide. Our Bloomington site is a state-of-the-art facility integrating process development, formulation, clinical and commercial biomanufacturing, drug product fill/finish, and packaging.


What We Offer

  • Competitive pay and annual performance bonus

  • Generous paid time off, including 14 paid holidays

  • Health, dental, and vision insurance effective day one

  • Guaranteed 8% 401K contribution plus company match option

  • Family-focused benefits: 14 weeks paid parental leave & 6 weeks paid family medical leave

  • Free access to Novo Nordisk-marketed pharmaceutical products

  • Tuition assistance

  • Life & disability insurance

  • Employee referral awards

  • Opportunities for career growth, mentorship, and skill development


Position Overview

The Drug Product Primary Manufacturing team produces sterile pharmaceuticals, including vials, syringes, and cartridges, inside sterile isolator barriers. This is a cleanroom environment requiring personnel to wear scrubs/coveralls, gloves, hairnets, safety glasses, and steel-toed shoes.

Reports to: Manufacturing Supervisor


Key Responsibilities

General Duties

  • Perform operations following established procedures with minimal supervision

  • Apply mathematical skills including addition, subtraction, multiplication, division, unit conversions, and significant figures

  • Participate in Continuous Improvement/Operational Excellence initiatives

  • Report safety and quality concerns; recommend improvements

  • Mentor and train onboarding employees

  • Troubleshoot basic equipment/process issues

  • Prepare technical reports and participate in investigations

  • Execute daily sanitizations, room clearances, and housekeeping within production areas

  • Ensure compliance with Good Documentation Practices (GDP) and aseptic behavior

Functional Areas

Formulation

  • Perform standard calculations for desired drug product mixtures

  • Aliquot liquids and powders per batch instructions

  • Conduct sterile filtration and filter testing

  • Clean and sterilize tanks using automated equipment

  • Train new employees on procedures

Filling

  • Perform in-line sterile filtration and filter testing

  • Set up, run, and troubleshoot complex machinery

  • Collect samples according to sampling plans

  • Count vials and syringes post batch execution

Preparation

  • Identify, retrieve, wash, clean, and sterilize equipment

  • Prepare small and large equipment assemblies

  • Perform post-batch reconciliation and filter testing

Material Staging (Pit Crew)

  • Stage and sanitize materials in classified areas

  • Coordinate material deliveries with Supply Chain

  • Verify material movements electronically

  • Deliver finished products to appropriate storage conditions


Physical Requirements

  • Frequent sitting, standing, walking, reaching, talking, reading, writing, and computer use

  • Occasional stooping, kneeling, crouching, bending, carrying up to 50 lbs

  • Compliance with EHS responsibilities

  • Work in controlled HVAC and cleanroom environments


Qualifications

Education & Experience

  • High School/GED required; Associate’s degree or higher preferred

  • Minimum 3 years of direct pharmaceutical manufacturing experience

  • Minimum 3 years of GMP experience

  • Experience with interventions during active aseptic filling

  • Experience operating Human Machine Interfaces (HMI) in aseptic filling, preferably with isolators

Technical Skills

  • Proficiency with Microsoft Office, Email, Teams

  • Ability to learn quality, operations, or scientific management software (e.g., ComplianceWire®, JD Edwards®)

  • Understanding and application of cGMPs

  • Knowledge of pharmaceutical laboratory or production operations

  • Ability to learn new principles and techniques with training

Behavioral Skills

  • Strong communication, time management, and organizational skills

  • Detail-oriented, able to work under pressure with multiple deadlines

  • Ability to collaborate with teams or work independently

  • Lead by example according to company values and culture

  • Promote compliance and provide constructive feedback

Leadership (If Applicable)

  • Serve as a designated trainer and Subject Matter Expert (SME)

  • Build trust and relationships with peers

  • Take initiative for professional development and procedural improvements


Diversity & Inclusion

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration regardless of race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other legally protected status.


Contact for Special Accommodation

For assistance with the application process, please call: 1-855-411-5290 (for accommodation requests only).