Aseptic Filling Operator - New Facility Start-Up

Novo Nordisk A/S; Clayton (NC); On-site; USD 48,000 - 72,000; Full time

Benefits offered by this job

Annual bonus

14 paid holidays

Insurance (health/dental/vision)

401k match

Parental leave

Product access

Life & disability insurance

Job summary

Novo Nordisk A/S in Clayton, NC seeks a hands-on production specialist to assist in aseptically operating Formulation, Wash/Sterilization, Filling and media preparations through documentation, startup and validation activities for a new production facility.

You will review job instructions and SOPs, support start-up and validation of new equipment, ensure aseptic conditions and environmental monitoring, and collaborate with SMEs while following safety and environmental requirements.

Qualifications

• Minimum two (2) years of experience in an FDA regulated environment.
• Aseptic processing experience is required.
• Isolator experience is preferred.

Responsibilities

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

Skills

Aseptic processing

Isolator experience

Education

High school diploma or equivalent

Job description

Novo Nordisk A/S in Clayton, NC seeks a hands-on production specialist to assist in aseptically operating Formulation, Wash/Sterilization, Filling and media preparations through documentation, startup and validation activities for a new production facility.

You will review job instructions and SOPs, support start-up and validation of new equipment, ensure aseptic conditions and environmental monitoring, and collaborate with SMEs while following safety and environmental requirements.