Director of Engineering & Maintenance (GMP Sterile)

Fraser Dove International; Michigan; On-site; USD 180,000 - 260,000; Full time

Job summary

Fraser Dove International, partnering with a leading US pharmaceutical manufacturer, seeks a Director of Engineering & Maintenance to lead engineering and maintenance excellence in a GMP sterile environment.

You will build a high-performing team, drive preventive and predictive maintenance, and lead CAPA‑driven improvements to uptime, OEE and batch performance while ensuring regulatory compliance.

Qualifications

• 10+ years engineering/maintenance leadership in regulated manufac­turing.
• GMP in sterile manufacturing experience preferred.
• Strong root-cause analysis and CAPA management skills.
• Ability to lead cross-functional technical teams.

Responsibilities

• Lead and develop engineering and maintenance teams with a culture of accountability and continuous improvement.
• Drive preventative, predictive and reliability-centred maintenance to improve uptime.
• Lead investigations for significant equipment failures and deviations using root cause analysis.
• Partner with QA, Validation, MSAT and other functions to strengthen CAPA and right-first-time manufacturing.
• Improve throughput, equipment utilization, OEE, and maintenance compliance using data-led analysis.
• Develop lifecycle plans and provide engineering support for commissioning, qualification and readiness.

Skills

Engineering leadership

Preventive maintenance

Predictive maintenance

Root cause analysis

CAPA management

CMMS

Lean Six Sigma

Data-driven decision making

GMP / sterile manufacturing

Education

Bachelor of Science in Engineering

Master's degree preferred

Tools

CMMS

Job description

Fraser Dove International, partnering with a leading US pharmaceutical manufacturer, seeks a Director of Engineering & Maintenance to lead engineering and maintenance excellence in a GMP sterile environment.

You will build a high-performing team, drive preventive and predictive maintenance, and lead CAPA‑driven improvements to uptime, OEE and batch performance while ensuring regulatory compliance.