Sterility Assurance Pro - Process Excellence & Lean

BioSpace; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

8% 401K company match

Parental & family leave

Tuition assistance

Life & disability insurance

Employee referral rewards

Job summary

Novo Nordisk is seeking a Process Professional to support operations, people, equipment, and processes in aseptic production and fill/finish. You will mentor junior staff, back up senior team members, and apply subject matter expertise to solve moderate to high complexity issues while ensuring regulatory compliance.

The role emphasizes Lean/Six Sigma, process data management, and collaboration across sites in a dynamic global manufacturing environment.

Qualifications

• Bachelor’s degree (engineering, technology or related field) from an accredited university required.
• Associate’s degree with minimum 4 years manufacturing experience preferred.
• High School Diploma with minimum 6 years manufacturing experience preferred.
• Minimum 2 years of manufacturing experience in pharmaceutical environment preferred.
• Excellent written communication skills.
• LEAN manufacturing experience and training required.
• General knowledge of change control systems and QMS required.
• Regulatory audits/inspections experience preferred.
• Knowledge of master data and electronic manufacturing systems (e.g., SAP, PAS-X) preferred.

Responsibilities

• Perform in-depth deviation investigations and root cause analysis.
• Drive continuous improvement using Lean tools and Six Sigma methods.
• Maintain area content and process knowledge.
• Identify and implement improvement opportunities for moderate to high complexity issues.
• Collaborate across sites and manage area master data and recipes as needed.
• Provide support on defined issues using subject matter expertise.
• Follow safety and environmental requirements in daily duties.
• Support training for junior team members.

Skills

Lean manufacturing

Problem solving

Written communication

Regulatory audits

QMS knowledge

Adult learning methods

Change control systems

GxP systems knowledge

Root cause analysis

Education

Bachelor's degree in engineering/tech

Associate's degree with 4+ years experience

High School Diploma with 6+ years experience

Tools

SAP

PAS-X

Job description

Novo Nordisk is seeking a Process Professional to support operations, people, equipment, and processes in aseptic production and fill/finish. You will mentor junior staff, back up senior team members, and apply subject matter expertise to solve moderate to high complexity issues while ensuring regulatory compliance.

The role emphasizes Lean/Six Sigma, process data management, and collaboration across sites in a dynamic global manufacturing environment.