Aseptic Production Operator – Start-up & Validation

BioSpace; Clayton (NC); On-site; USD 45,000 - 70,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K + match

Paid time off

Parental leave

Life Insurance

Disability Insurance

Tuition Assistance

Job summary

Novo Nordisk in North Carolina is seeking personnel to support aseptic processing at a new facility. The role emphasizes startup, qualification, and ongoing adherence to documented SOPs and safety standards. The environment is FDA-regulated with focus on quality and continuous improvement.

The position offers comprehensive benefits and opportunities for growth within a global healthcare leader.

Qualifications

• High school diploma or equivalent required.
• Minimum two (2) years of experience in an FDA regulated environment required.
• Isolator experience preferred.
• Ability to read, write & understand complicated product documentation & standard operating procedures with attention to detail required.
• Computer literacy required.
• Expertise in planning/organizing, managing execution, checking results & revising work plan preferred.

Responsibilities

• Review and author Job Instructions, SOPs and other documents.
• Assist in start-up and validation of new equipment.
• Review standards to maintain aseptic areas and perform sanitizations and environmental monitoring.
• Support event response planning.
• Assist maintenance team in developing protocols for restoration of lost function, predictive and preventative maintenance.
• Support SMEs in training fellow employees in areas of expertise, including learning systems and equipment outside of area of expertise.
• Follow all safety and environmental requirements in the performance of duties.
• Other duties as assigned.

Skills

Attention to detail

Computer literacy

Education

High school diploma or equivalent

Job description

Novo Nordisk in North Carolina is seeking personnel to support aseptic processing at a new facility. The role emphasizes startup, qualification, and ongoing adherence to documented SOPs and safety standards. The environment is FDA-regulated with focus on quality and continuous improvement.

The position offers comprehensive benefits and opportunities for growth within a global healthcare leader.