API Manufacturing Operator – Utilities & GMP

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 52,000 - 74,000; Full time

Benefits offered by this job

Leading pay

14 paid holidays

Health Insurance from day one

401K with 8% company match

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Free access to Novo Nordisk products

Job summary

Novo Nordisk in Clayton, NC seeks a manufacturing Operator to support API-US production. You will operate utility and RMS process equipment, receive materials, complete training, and support quality and financial goals ensuring safety.

You will maintain relations with internal and external stakeholders, follow EHS guidelines, and work with validated systems like BMS, PCS, and Life Safety to minimize downtime.

Qualifications

• High school diploma or GED required.
• Bachelor’s Degree in a relevant field preferred.
• BioWork certification or equivalent a plus.
• Minimum 6 months of related experience in a regulated industry required.
• Knowledge of utility and raw material systems in a regulated environment (FDA, cGMP, OSHA) is a plus.
• Experience with data-driven problem solving and event response.
• Basic knowledge of production utilities or raw material handling is preferred.
• Ability to work with electronic batch records and automated process equipment (DeltaV/Syncede preferred).
• Ability to read equipment documents with a basic understanding.
• Understanding of SOPs and cGMP documentation; strong attention to detail.
• Computer literacy with associated systems required.
• Proven ability to check results and revise tasks to meet daily plan.

Responsibilities

• Operate equipment and processes following SOPs for nGMP and cGMP systems.
• Identify and document anomalies to minimize downtime and ensure safety.
• Maintain standards and procedures for automated and manual systems.
• Support control systems (BMS, PCS, Life Safety) and respond to issues.
• Assist stakeholders for successful plant operations including maintenance and optimization.
• Execute raw material movement and offload into process systems.
• Perform site rounds and equipment inspections to ensure compliant operations.
• Adhere to quality and environmental regulations.

Skills

Regulated industry experience

Problem solving

Electronic batch records

Education

Bachelor’s Degree in a relevant field

High school graduate or GED

BioWork certification

Tools

DeltaV

Syncade

Job description

Novo Nordisk in Clayton, NC seeks a manufacturing Operator to support API-US production. You will operate utility and RMS process equipment, receive materials, complete training, and support quality and financial goals ensuring safety.

You will maintain relations with internal and external stakeholders, follow EHS guidelines, and work with validated systems like BMS, PCS, and Life Safety to minimize downtime.