Pharma Packaging Setup Specialist

Guerbet; Raleigh (NC); On-site; USD 42,000 - 64,000; Full time

Job summary

Guerbet seeks a Packaging Setup Operator to run and monitor pharmaceutical packaging equipment in a cGMP environment. You will perform line setup, changeovers, and document batch records with precision to ensure quality and regulatory compliance.

Responsibilities include uptime tracking, sanitation, and adherence to FDA/EMA guidelines, while maintaining safety and productive operations to ensure reliable supply of products to patients.

Qualifications

• High School Diploma, GED, or equivalent required.
• 2-4 years pharmaceutical experience as a Production Operator or Setup Operator in a controlled pharmaceutical manufacturing environment preferred.
• Knowledge of basic computer skills and Microsoft Office.

Responsibilities

• Setup and monitor packaging equipment within validated parameters while performing inspections, verifying components, packaging acceptable units, and maintaining required production documentation.
• Perform routine line setup, changeovers, and equipment adjustments to support scheduled packaging runs.
• Accurately record all downtimes in the GPS systems in real time in support of production tracking.
• Clean and sanitize production areas and equipment in accordance with established procedures and safety standards.
• Demonstrate understanding of Current Good Manufacturing Practices (cGMP) and applicable regulatory guidelines (FDA, EMA, etc.)
• Accurately complete all documentation, including batch records and logbooks, in compliance with cGMP and data integrity requirements.

Skills

Interpersonal skills

Attention to detail

Mathematical aptitude

Problem solving

Education

High School Diploma, GED, or equivalent

Tools

Microsoft Office

Job description

Guerbet seeks a Packaging Setup Operator to run and monitor pharmaceutical packaging equipment in a cGMP environment. You will perform line setup, changeovers, and document batch records with precision to ensure quality and regulatory compliance.

Responsibilities include uptime tracking, sanitation, and adherence to FDA/EMA guidelines, while maintaining safety and productive operations to ensure reliable supply of products to patients.