Technical Operations Leader – cGMP Manufacturing

Alcami Corporation; Clinton (TN); On-site; USD 75,000 - 95,000; Full time

Job summary

Alcami Corporation in US-TN-Clinton is seeking a Technical Operations Specialist to support cGMP manufacturing with technical oversight and issue resolution. You will execute continued process verification activities, monitor process performance, and provide ongoing technical support to manufacturing teams.

This on-site role emphasizes collaboration with Quality, Engineering, and EHS, plus leading training and documenting reviews, batch records, and change controls to ensure product quality and

Qualifications

• At least 5 years of experience in a pharmaceutical cGMP Manufacturing setting.
• Bachelor's degree preferred.
• Minimum 1 year of Technical Writing experience (deviations, SOPs, Batch Records).
• Demonstrated leadership and training experience.
• Proficiency with Microsoft Office Suite preferred.

Responsibilities

• Manufacturing & Process Support: troubleshoot events and ensure compliant production.
• Process Verification & Technical Oversight: CPV activities and performance monitoring.
• Cross-Functional Collaboration & Coordination: resolve documentation and CAPAs across teams.
• Documentation Management & Training: route reviews, create standard work, train staff.

Skills

Leadership

Technical Writing

Data analysis

Communication

Problem solving

Education

Bachelor's degree in related field

Tools

Microsoft Office

Job description

Alcami Corporation in US-TN-Clinton is seeking a Technical Operations Specialist to support cGMP manufacturing with technical oversight and issue resolution. You will execute continued process verification activities, monitor process performance, and provide ongoing technical support to manufacturing teams.

This on-site role emphasizes collaboration with Quality, Engineering, and EHS, plus leading training and documenting reviews, batch records, and change controls to ensure product quality and