API Manufacturing Associate I

Novo Nordisk

. Operate API manufacturing equipment to achieve production goals .

Posted 10/15/2026full-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 GMP standards and safety guidelines. Proficient in troubleshooting mechanical systems and maintaining compliance with regulatory requirements in a pharmaceutical manufacturing environment.

Highest-signal resume keywords

GMP DocumentationAPI Manufacturing Equipment OperationTroubleshooting Mechanical SystemsCGMP Manufacturing KnowledgeMicrosoft Office Suite Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Manufacturing ExperienceProblem SolvingMaterial HandlingSOP ComplianceEnvironmental MonitoringEquipment MaintenanceData AnalysisQualification and Validation ActivitiesBasic Biology KnowledgeBasic Chemistry Knowledge

Soft Skills

Attention to DetailSystematic ApproachTeam CollaborationEffective CommunicationAdaptability

Tools & Technologies

Computer-Driven Manufacturing EquipmentMaterial Handling EquipmentLock Out Tag Out Systems

Certifications & Qualifications

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

Industry Keywords

FDA Regulated EnvironmentCGMP StandardsPharmaceutical ManufacturingISO StandardsEnvironmental Responsibility

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 products from trucks, tankers, and ISO containers
Execute the production schedule to achieve production goals
Troubleshoot equipment and assist with equipment maintenance, including restoration of lost function and predictive and preventative maintenance
Maintain clean room areas and perform environmental monitoring
Report to the Shift Manager, Operations – API
Perform other assigned accountabilities

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 operation of computer-driven manufacturing/production equipment and efficient use of 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 and effectively use material handling equipment required
Ability to ensure 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 occasionally ascend/descend ladders and work at elevated heights
Ability to work around odorous and/or hazardous materials
Ability to work in loud noise environments with hearing protection
May be required to secure a motorized vehicle license and operate 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