Manufacturing Operations Specialist

Katalyst CRO; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Katalyst CRO in Durham, NC seeks a Manufacturing Operations Specialist to support pharmaceutical manufacturing—operating production equipment, executing batch records, and maintaining GMP compliance for safe, efficient operations.

Responsibilities include equipment changeovers, electronic batch documentation, deviation support, and participation in shift handoffs and continuous improvement initiatives. A relevant degree is required.

Qualifications

• Must have pharmaceutical/biotech manufacturing experience.
• Experience with GMP facilities or regulated environments.
• Familiarity with electronic batch records and manufacturing systems.
• Experience operating automated manufacturing equipment.

Responsibilities

• Operate manufacturing equipment following SOPs and batch records.
• Execute manufacturing processes in GMP-compliant manner.
• Complete electronic batch documentation accurately.
• Perform equipment cleaning and changeovers.
• Monitor production processes and identify abnormalities.
• Support deviation investigations and corrective actions.
• Maintain inventory of manufacturing supplies.
• Participate in shift handoffs and production meetings.
• Follow safety and environmental procedures.
• Support continuous process improvement initiatives.

Skills

Operate equipment

GMP compliance

Electronic batch records

Batch documentation

Process improvement

Safety procedures

Education

Associate or Bachelor's in biology/ Biotechnology/ Chemistry

Tools

Automated manufacturing equipment

Manufacturing systems

Job description

Summary

The Manufacturing Operations Specialist supports pharmaceutical manufacturing activities by operating production equipment, executing batch records, and maintaining compliance with GMP standards while ensuring safe and efficient operations.

Roles & Responsibilities

• Operate manufacturing equipment following SOPs and batch records.
• Execute manufacturing processes in accordance with GMP requirements.
• Complete electronic batch documentation accurately.
• Perform equipment cleaning and changeovers.
• Monitor production processes and identify abnormalities.
• Support deviation investigations and corrective actions.
• Maintain inventory of manufacturing supplies.
• Participate in shift handoffs and production meetings.
• Follow all safety and environmental procedures.
• Support continuous process improvement initiatives.

Requirements

• 24 years of pharmaceutical or biotechnology manufacturing experience.
• Experience working in GMP-regulated facilities.
• Familiarity with electronic batch records and manufacturing systems.
• Experience operating automated manufacturing equipment.
• Associate or bachelor's degree in biology, Biotechnology, Chemistry, or related field.