Principal Engineer - GMP & Process Systems Lead

ProQuality Network; United States; Hybrid; USD 140,000 - 210,000; Full time

Job summary

ProQuality Network is seeking a Principal Engineer to provide technical leadership for complex manufacturing, utility, facility, and process projects in a highly regulated environment. You will drive design, modification, maintenance, and optimization of systems and processes, collaborating with Manufacturing, Facilities, QA, Validation, and Process Development teams.

The role emphasizes GMP/GLP compliance, CAPA management, and rigorous documentation, requiring strong problem-solving,

Qualifications

• Bachelor's degree in engineering with 6+ years of related experience, or advanced degree with fewer years.
• Experience in pharmaceutical/biotechnology regulated environments.
• Strong problem-solving and communication skills.

Responsibilities

• Lead and coordinate large-scale engineering projects across facilities, utilities, and manufacturing processes.
• Develop and manage budgets for complex projects.
• Ensure GMP/GLP compliance and support CAPA investigations.
• Collaborate with cross-functional teams to implement system modifications.
• Provide SME in multiple engineering disciplines.

Skills

Cross-Functional Leadership

Regulatory Compliance

GMP/GLP Knowledge

Process Optimization

Technical Troubleshooting

Education

Bachelor's Degree in Engineering

Master's Degree in Engineering

Doctorate Degree in Engineering

Job description

ProQuality Network is seeking a Principal Engineer to provide technical leadership for complex manufacturing, utility, facility, and process projects in a highly regulated environment. You will drive design, modification, maintenance, and optimization of systems and processes, collaborating with Manufacturing, Facilities, QA, Validation, and Process Development teams.

The role emphasizes GMP/GLP compliance, CAPA management, and rigorous documentation, requiring strong problem-solving,