Lead Process Engineer - Safety & GMP Excellence

Fraser Dove International; Virginia (MN); On-site; USD 110,000 - 160,000; Full time

Job summary

Fraser Dove International partners with a dynamic pharmaceutical manufacturer in Virginia to recruit a senior Process Engineer responsible for leading design and implementation of processes with a strong focus on safety, quality and efficiency.

You will mentor junior engineers, ensure cGMP compliance, develop GMP documentation and train operators while driving improvements across the plant and supporting audits.

Qualifications

• Bachelor’s degree in chemical engineering.
• 8–14 years of related experience with a bachelor’s degree or 7–11 years with a master’s degree.
• Experience in a cGMP environment is preferred.

Responsibilities

• Lead process design initiatives to improve safety, quality and productivity.
• Provide mentorship and training to less senior staff on best practices and process design.
• Ensure compliance with cGMP guidelines and contribute to GMP documentation and operator training.
• Lead Process Safety information completion and participate in Process Hazard Analysis.
• Design projects to enhance safety, quality and productivity.
• Generate GMP documentation and lead operator training sessions.
• Monitor and manage process performance and implement improvements.
• Oversee product changeovers, set up operations, and prepare cleaning instructions.
• Provide leadership during plant audits and contribute to CAPA writing and implementation.
• Mentor junior engineers on quality and safety practices.

Skills

Process engineering

Safety focus

Quality emphasis

Mentorship

cGMP

Communication

Education

Bachelor’s degree in chemical engineering

Job description

Fraser Dove International partners with a dynamic pharmaceutical manufacturer in Virginia to recruit a senior Process Engineer responsible for leading design and implementation of processes with a strong focus on safety, quality and efficiency.

You will mentor junior engineers, ensure cGMP compliance, develop GMP documentation and train operators while driving improvements across the plant and supporting audits.