What are the responsibilities and job description for the Operator I - Utility & RMS position at BioSpace?
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 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
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.
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.
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 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
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.
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.