Aseptic Manufacturing Cell Lead

Novo Nordisk; Clayton (NC); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

Lead ing pay and bonus

Paid time off

Health Insurance

401K with company match

Parental & family leave

Product samples

Tuition Assistance

Life & Disability Insurance

Employee Referral Awards

Job summary

Novo Nordisk's Product Supply Aseptic Manufacturing (PS AM) site in Clayton, NC is seeking a skilled operator to ensure safe and efficient operation of a work cell, upholding quality standards.

You will lead daily production activities, monitor equipment, enforce safety and environmental requirements, coordinate maintenance, and support a productive, engaged team. Strong attention to SOPs and cGMP documentation is essential.

Qualifications

• High school diploma or equivalent required; associate's degree preferred.
• BioWork graduate preferred.
• Minimum 2 years of manufacturing experience, FDA regulated environment.
• Qualified to operate work cell equipment.
• Ability to read and write complicated product documentation and SOPs; computer literacy preferred.
• Experience with planning, organizing, and meeting daily work plan targets.
• Ability to troubleshoot and participate in event response; document problems for rapid resolution.

Responsibilities

• Execute production plan by leading the operation and monitoring equipment within the work cell.
• Enforce safety and environmental requirements in daily duties.
• Set up the next shift for success.
• Coordinate maintenance activities as scheduled by Maintenance Planning.
• Lead team in Event Response/ RCA with support from Process Engineer & Supervisor.
• Schedule work cell resources including breaks and meals.
• Address safety, quality, staffing, or personnel issues and escalate as needed.
• Monitor training and ensure competency of team members.
• Responsible for cGMP documentation.
• Provide performance review input for work cell members as required.
• Spend 20%–50% of time operating as an operator in the process.
• Other accountabilities as assigned.

Skills

Detail oriented

Problem solving

Planning & organizing

Event response

SOP literacy

Communication

Education

High school graduate or equivalent

Associate's Degree in related field

BioWork graduate

Job description

Novo Nordisk's Product Supply Aseptic Manufacturing (PS AM) site in Clayton, NC is seeking a skilled operator to ensure safe and efficient operation of a work cell, upholding quality standards.

You will lead daily production activities, monitor equipment, enforce safety and environmental requirements, coordinate maintenance, and support a productive, engaged team. Strong attention to SOPs and cGMP documentation is essential.