API Manufacturing Associate I

Novo Nordisk

Operate manufacturing equipment to achieve production goals in a pharmaceutical company focusing on innovative oral products. Contribute to the production process while adhering to safety and compliance standards.

Posted 7/23/2026full-timeClayton • North Carolina • 🇺🇸 United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in operating API manufacturing equipment while adhering to cGMP standards and SOPs. Proficient in troubleshooting, maintaining equipment, and ensuring compliance with safety guidelines in a regulated manufacturing environment.

Highest-signal resume keywords

API Manufacturing Equipment OperationCGMP ComplianceSOP AdherenceTroubleshooting SkillsMaterial Handling

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Manufacturing ExperienceProblem SolvingData AnalysisMechanical AptitudeBiology KnowledgeChemistry KnowledgeEquipment MaintenanceEnvironmental MonitoringProduction SchedulingLock Out Tag Out Systems

Soft Skills

Attention to DetailTeam ParticipationEffective Communication

Tools & Technologies

Computer Driven Manufacturing EquipmentMicrosoft Office Suite

Certifications & Qualifications

High School GraduateAssociate's Degree in Tech, Science, or Engineering

Industry Keywords

FDA Regulated EnvironmentCGMP ManufacturingISO StandardsSOP DocumentationQualification and Validation Activities

About the role

Key responsibilities & impact

Operate API manufacturing equipment to achieve production goals.
Work in a safe & environmentally responsible manner
Follow instructions listed in GMP documentation & product quality
Review SOP’s & other documents, as required
Real time review of electronic batch records ensuring compliance to Standard Operating Procedures (SOPs) & current Good Manufacturing Practices (cGMP) standards
Manage individual training plan
Participate in qualification & validation activities as required
Setup, operate, monitor, & control highly automated processes & systems
Load & unload product from trucks, tankers & ISO containers, as required
Execute production schedule to achieve production goals
Utilize investigation skills during troubleshooting & assist during equipment maintenance, including restoration of lost function, predictive & preventative maintenance
Maintain clean room areas & perform environmental monitoring, as required
Other accountabilities, as assigned

Requirements

What you’ll need

High school graduate or equivalent required
Associate's Degree or higher in Tech, Science, or Engineering preferred
BioWork or equivalent industrial, military or vocational training combined with experience preferred
Minimum two (2) years of manufacturing experience in FDA regulated environment preferred
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
Experience following SOPs to perform tasks & raising issues if errors are found preferred
Experience following established safety guidelines when performing tasks preferred
Computer literacy including, but not limited to, ability to operate computer driven manufacturing/production equipment & efficient use of Microsoft Office suite programs required
Ability to read & understand complicated product documentation & standard operating procedures with attention to detail required
Ability to perform basic material handling tasks, safely & effectively use material handling equipment required
Ensure compliance with corporate/local SOPs, regulations & ISO standards required
General knowledge in cGMP manufacturing & production processes associated with pharmaceutical companies required
Basic knowledge of biology/chemistry preferred
Mechanical aptitude, ability to follow use tools to perform tasks, basic troubleshooting of mechanical components & systems preferred
Experience working with work permits/Lock Out Tag Out systems preferred

Benefits

Comp & perks

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