Aseptic Process & Sterilization Associate I

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

Benefits offered by this job

Health Insurance

14 paid holidays

8% 401K company match

Parental & family leave

Tuition Assistance

Life & Disability Insurance

Job summary

Novo Nordisk in Clayton, NC, seeks a Process Improvement Engineer to support operations, analyze deviations with QA, and drive Lean-based improvements. You will mentor teammates and help implement effective process changes in a regulated pharmaceutical setting.

Strong problem-solving, GMP knowledge, and ability to train others are essential for success. This role emphasizes training, compliance, and cross-functional teamwork.

Qualifications

• Bachelor’s degree in engineering, technology or related field required.
• Minimum of one year of manufacturing experience preferred, ideally in pharma.
• GMP knowledge and strong written communication are essential.
• Experience with change control and QMS systems is preferred.
• Exposure to regulatory audits is a plus.

Responsibilities

• Lead in depth deviation investigations and root cause analysis with QA.
• Drive continuous improvement using Lean tools and methods.
• Provide training on process changes to junior team members.
• Identify and implement routine to moderate process improvements.
• Collect data for periodic reviews and reporting.
• Adhere to safety and environmental requirements in duties.

Skills

Excellent written communication

GMP knowledge

Problem-solving

Adult learning methodologies

Training others

Change control knowledge

QMS knowledge

Regulatory audits exposure

Education

Bachelor's degree in engineering/technology or related field

Associate's degree with 2+ years manufacturing experience

High School Diploma with 4+ years manufacturing experience

Tools

SAP

PAS-X

Job description

Novo Nordisk in Clayton, NC, seeks a Process Improvement Engineer to support operations, analyze deviations with QA, and drive Lean-based improvements. You will mentor teammates and help implement effective process changes in a regulated pharmaceutical setting.

Strong problem-solving, GMP knowledge, and ability to train others are essential for success. This role emphasizes training, compliance, and cross-functional teamwork.