Senior Calibration & Engineering Leader – GMP Pharma

DifGen Pharmaceuticals; Town of Florida (NY); On-site; USD 150,000 - 230,000; Full time

Job summary

DifGen Pharmaceuticals in Tamarac, FL is seeking an accomplished Senior Engineering Leader to set and execute the engineering strategy for the site, aligning with operational objectives and technology upgrades.

The role leads cross-functional initiatives for capacity expansion, equipment modernization, and continuous improvement, ensuring FDA/DEA compliance and site readiness for audits while developing a high‑performing maintenance team.

Qualifications

• Associate's or Bachelor's degree in engineering with pharmaceutical GMP experience.
• Experience leading engineering in GMP manufacturing environments with aseptic experience preferred.

Responsibilities

• Develop and execute the site's engineering strategy aligned with objectives and technology upgrades.
• Lead calibration, design, budgeting, and scheduling for capital projects and facility upgrades.
• Oversee equipment installation, qualification, and scale-up of new products.
• Ensure FDA/DEA/compliance and audit readiness; support quality and regulatory priorities.
• Build, mentor, and manage a high-performing engineering and maintenance team.
• Drive EH&S risk assessment, training, and safety program improvements.

Skills

Strategic leadership

Cross-functional leadership

Regulatory compliance

GMP familiarity

Education

Bachelor's degree in engineering

Job description

DifGen Pharmaceuticals in Tamarac, FL is seeking an accomplished Senior Engineering Leader to set and execute the engineering strategy for the site, aligning with operational objectives and technology upgrades.

The role leads cross-functional initiatives for capacity expansion, equipment modernization, and continuous improvement, ensuring FDA/DEA compliance and site readiness for audits while developing a high‑performing maintenance team.