API Manufacturing Associate I – Night Shift

Novo Nordisk

. Operate API manufacturing equipment to achieve production goals .

Posted 9/23/2026full-timeClayton • North Carolina • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in operating API manufacturing equipment while adhering to GMP standards and safety regulations. Proficient in troubleshooting mechanical systems and maintaining compliance with production documentation and quality requirements.

Highest-signal resume keywords

API Manufacturing Equipment OperationGMP ComplianceTroubleshooting Mechanical SystemsSOP AdherenceProduction Schedule Execution

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Manufacturing ExperienceProblem SolvingData AnalysisMaterial HandlingMechanical AptitudeCGMP KnowledgeBiology KnowledgeChemistry KnowledgeEquipment InspectionLock Out Tag Out Systems

Soft Skills

Attention to DetailTeam CollaborationEffective Communication

Tools & Technologies

Microsoft Office SuiteComputer-Driven Manufacturing Equipment

Certifications & Qualifications

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

Industry Keywords

FDA Regulated EnvironmentPharmaceutical ManufacturingEnvironmental MonitoringCleanroom MaintenanceISO 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 other documents
Review electronic batch records in real time for SOP and cGMP compliance
Manage an 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 using investigation skills and assist with equipment maintenance, including restoration of lost function and predictive/preventive maintenance
Maintain cleanroom 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 to perform tasks and raising issues if errors are found preferred
Experience following established safety guidelines when performing tasks preferred
Computer literacy, including operating 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 work in loud-noise environments with hearing protection
May require corrected vision to 20/20 or 20/25 and color vision
May require securing a motorized vehicle license and operating a motorized vehicle

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