MS&T Process Engineer — Tech Transfer & Optimization

American Injectables; Brooksville (FL); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Dental insurance

401(k)

Job summary

American Injectables is seeking a Senior MS&T Engineer to lead technology transfers for sterile manufacturing, develop critical batch records and specifications, and provide process support. You will guide deviation assessment, change controls, and cross-functional collaboration to ensure compliant, high-quality operations.

The role emphasizes continuous improvement, mentoring team members, and adherence to regulatory, safety, and sustainability requirements.

Qualifications

• Bachelor's degree in engineering, biology, chemistry, or related science required.
• 10+ years of manufacturing/engineering/validation/technology transfer experience in pharma preferred.
• Experience with process simulations, start-up and scale-up from R&D is desirable.
• Proven project leadership, strong communication, and teamwork required.

Responsibilities

• Lead technology transfers from internal and external sources.
• Develop batch records, procedures, specifications and support sterile manufacturing.
• Oversee process validation batches and perform risk assessments and optimization tests.
• Support validation, commissioning, installation, and cleaning validation activities.
• Identify opportunities to reduce costs and improve quality, yield, and compliance.
• Address deviations and CAPA through root-cause analysis and robust documentation.

Skills

Project leadership

Analytical thinking

Team player

Organized

Problem solving

Education

Bachelor's degree in engineering/biology/chemistry or related science

Tools

MS Word

MS Excel

MS PowerPoint

MS Project

MS Visio

Job description

American Injectables is seeking a Senior MS&T Engineer to lead technology transfers for sterile manufacturing, develop critical batch records and specifications, and provide process support. You will guide deviation assessment, change controls, and cross-functional collaboration to ensure compliant, high-quality operations.

The role emphasizes continuous improvement, mentoring team members, and adherence to regulatory, safety, and sustainability requirements.