Operator I - Utility & RMS

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 52,000 - 74,000; Full time

Benefits offered by this job

Leading pay

14 paid holidays

Health Insurance from day one

401K with 8% company match

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Free access to Novo Nordisk products

Job summary

Novo Nordisk in Clayton, NC seeks a manufacturing Operator to support API-US production. You will operate utility and RMS process equipment, receive materials, complete training, and support quality and financial goals ensuring safety.

You will maintain relations with internal and external stakeholders, follow EHS guidelines, and work with validated systems like BMS, PCS, and Life Safety to minimize downtime.

Qualifications

• High school diploma or GED required.
• Bachelor’s Degree in a relevant field preferred.
• BioWork certification or equivalent a plus.
• Minimum 6 months of related experience in a regulated industry required.
• Knowledge of utility and raw material systems in a regulated environment (FDA, cGMP, OSHA) is a plus.
• Experience with data-driven problem solving and event response.
• Basic knowledge of production utilities or raw material handling is preferred.
• Ability to work with electronic batch records and automated process equipment (DeltaV/Syncede preferred).
• Ability to read equipment documents with a basic understanding.
• Understanding of SOPs and cGMP documentation; strong attention to detail.
• Computer literacy with associated systems required.
• Proven ability to check results and revise tasks to meet daily plan.

Responsibilities

• Operate equipment and processes following SOPs for nGMP and cGMP systems.
• Identify and document anomalies to minimize downtime and ensure safety.
• Maintain standards and procedures for automated and manual systems.
• Support control systems (BMS, PCS, Life Safety) and respond to issues.
• Assist stakeholders for successful plant operations including maintenance and optimization.
• Execute raw material movement and offload into process systems.
• Perform site rounds and equipment inspections to ensure compliant operations.
• Adhere to quality and environmental regulations.

Skills

Regulated industry experience

Problem solving

Electronic batch records

Education

Bachelor’s Degree in a relevant field

High school graduate or GED

BioWork certification

Tools

DeltaV

Syncade

Job description

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. 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.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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 14weeks 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

The purpose of the position is to operate utility and RMS process equipment to support API-US production. Responsibilities include operation of applicable equipment within the scope of the department. Other duties will be receiving materials, completing training and supporting quality & financial goals for the site. Establish & maintain positive working relationships with internal & external stakeholders and ensure all activities are aligned with Environmental Health & Safety (EHS) program expectations.

Relationships

Reports to Manager.

Essential Functions

• Operate equipment and processes following Standard Operating Procedures for both nGMP and GMP systems
• Identify and document system or operational anomalies for cause & clearance to minimize downtime and ensure a safe working environment
• Maintain standards & operational procedures for automated and manually operated systems
• Support consistent operation, maintenance & response for all control systems (BMS, PCS, Life Safety)
• Support stakeholders as required for successful plant operations including maintenance and optimization activities
• Execute raw material movement and offload into process systems
• Execute site rounds and equipment inspections independently to ensure efficient and compliant operations
• Adhere to all Quality & Environmental regulations
• Participate in systematic problem-solving efforts
• Manage individual training plan
• Perform routine cleaning and good housekeeping as needed for assigned areas
• Review electronic batch records real-time to ensure compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

Physical Requirements

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Strap & unstrap pallets using hands. Must be able to be on your feet for up to a 12-hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. May be required to wear latex gloves. May perform critical job functions in extremely cold work environments depending on site. May position oneself within confined spaces for inspection if required of the role. Ability to work in loud noise environments with hearing protection. May be required to secure a motorized vehicle license & operate a motorized vehicle based on the role.

Qualifications

• High school graduate or GED required
• Bachelor’s Degree in a relevant field of study from an accredited university preferred
• BioWork certification or equivalent a plus
• Minimum of 6 months of related experience in regulated industry required
• Knowledge & experience in the operations and maintenance of utility and raw material systems, as well as working in a regulated environment (FDA, cGMP, OSHA) a plus
• Experience demonstrating a systematic approach to problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred
• Basic knowledge of production utility systems or raw material handling such as: purified water, process air, chemical storage & process waste systems preferred
• Ability to work with electronic batch records, automated process equipment, and/or DeltaV or Syncade preferred
• Ability to read/review equipment documents with a basic understanding preferred
• Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts a plus
• Computer literacy with associated systems required
• Proven ability to check results & revise work tasks to meet daily plan preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.