API Manufacturing Associate I

Novo Nordisk

. Operate API manufacturing equipment to achieve production goals .

Posted 11/4/2026full-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 safety guidelines. Proficient in troubleshooting mechanical systems and maintaining compliance with SOPs and FDA regulations.

Highest-signal resume keywords

API Manufacturing Equipment OperationCGMP ComplianceTroubleshooting Mechanical SystemsSOP DocumentationMaterial Handling

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Manufacturing ExperienceProblem SolvingData AnalysisMechanical AptitudeBasic Biology KnowledgeBasic Chemistry KnowledgeEquipment MaintenanceEnvironmental MonitoringLock Out Tag Out SystemsMaterial Handling Equipment Operation

Soft Skills

Attention to DetailTeam CollaborationCommunication Skills

Tools & Technologies

Computer-Driven Manufacturing EquipmentMicrosoft Office Suite

Certifications & Qualifications

High School Diploma or EquivalentAssociate's Degree in Tech, Science, or Engineering (Preferred)

Industry Keywords

FDA Regulated EnvironmentCGMP ManufacturingPharmaceutical ProductionSOPsISO Standards

About the role

Key responsibilities & impact

Operate API manufacturing equipment to achieve production goals
Work in a safe and environmentally responsible manner
Follow GMP documentation, product quality requirements, SOPs, and cGMP standards
Review SOPs and other documents as required
Conduct real-time review of electronic batch records
Manage individual training plan
Participate in qualification and validation activities
Set up, operate, monitor, and control highly automated processes and systems
Load and unload product from trucks, tankers, and ISO containers
Execute the production schedule to achieve production goals
Troubleshoot using investigation skills and assist with equipment maintenance, including restoration of lost function and predictive and preventative maintenance
Maintain clean room areas and perform environmental monitoring as required
Perform other assigned accountabilities
Report to the Shift Manager, Operations – API

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 and troubleshooting based on data and facts preferred
Experience participating in and driving event response activities preferred
Experience documenting problems, ensuring rapid resolution, and preventing recurrence preferred
Experience following SOPs and raising issues if errors are found preferred
Experience following established safety guidelines preferred
Computer literacy, including operating computer-driven manufacturing/production equipment and using Microsoft Office suite programs required
Ability to read and understand complicated product documentation and standard operating procedures with attention to detail required
Ability to perform basic material handling tasks and safely use material handling equipment required
Compliance with corporate/local SOPs, regulations, and ISO standards required
General knowledge of cGMP manufacturing and production processes associated with pharmaceutical companies required
Basic knowledge of biology/chemistry preferred
Mechanical aptitude and ability to use tools to perform tasks preferred
Basic troubleshooting of mechanical components and systems preferred
Experience working with work permits/Lock Out Tag Out systems preferred
Ability to move equipment and/or supplies weighing up to 33 pounds
Ability to stand for up to a 12-hour shift
Ability to operate and inspect manufacturing equipment using hands
Ability to work in loud-noise environments with hearing protection
Ability to occasionally ascend/descend ladders and potentially work at elevated heights
Ability to work around odorous and/or hazardous materials
May require corrected vision to 20/20 or 20/25 and color vision, depending on role
May require wearing latex gloves and working in extremely cold environments, depending on site
May require positioning oneself in confined spaces for inspection
May require securing a motorized vehicle license and operating a motorized vehicle, based on the role

Benefits

Comp & perks

Leading pay and annual performance bonus for all positions
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
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, resources, and mentorship to help grow and build your career