Principal Engineer 35423

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

Title: Principal Engineer (Job ID: 35423)

Shift: Administrative Shift

Contract Duration: 1 Year

Open Positions: 1

Position Summary

Our Client is seeking an experienced Principal Engineer to provide technical leadership and engineering expertise in support of complex manufacturing, utility, facility, and process-related projects within a highly regulated environment.

This position is responsible for leading and coordinating multiple large-scale, non-routine engineering projects involving the planning, design, modification, construction, maintenance, and optimization of systems, facilities, utilities, and manufacturing processes. The successful candidate will leverage expertise across multiple engineering disciplines to support process characterization, process optimization, scale-up activities, manufacturing operations, and continuous improvement initiatives.

The Principal Engineer will work closely with cross-functional teams, including Manufacturing, Process Development, Facilities, Utilities, Quality Assurance, Validation, and Research organizations to drive strategic projects and ensure compliance with regulatory and business requirements.

Key Responsibilities

• Establish and implement engineering policies, standards, and best practices for major organizational initiatives.
• Interpret, execute, and recommend improvements to company-wide engineering policies and procedures.
• Develop and manage organizational and project budgets for large-scale or highly complex engineering projects.
• Apply advanced engineering principles, theories, and technical concepts to solve complex operational and process challenges.
• Lead in-depth engineering investigations, define project scope, evaluate alternatives, and develop innovative technical solutions.
• Plan and conduct engineering research and technical assessments involving systems, facilities, equipment, utilities, and manufacturing processes.
• Coordinate and provide technical leadership to engineers, contractors, and technical personnel.
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to define requirements and implement complex system, facility, or process modifications.
• Serve as a technical subject matter expert (SME) in multiple engineering disciplines.
• Lead engineering and process improvement projects that support critical business objectives and operational goals.
• Support investigations related to GMP events, deviations, root cause analysis, corrective and preventive actions (CAPAs), and continuous improvement initiatives.
• Ensure compliance with applicable GMP, GLP, safety, quality, and regulatory requirements.
• Perform additional duties and special projects as assigned.

Minimum Qualifications

• Bachelor's Degree in Engineering with a minimum of 6 years of related engineering experience, OR
• Master's Degree in Engineering with a minimum of 4 years of related engineering experience, OR
• Doctorate Degree in Engineering with a minimum of 2 years of related engineering experience.

Preferred Qualifications

• Experience supporting Clean Utilities systems within pharmaceutical, biotechnology, or highly regulated manufacturing environments.
• Experience conducting GMP investigations, deviation management, root cause analysis, and documentation activities.
• Strong understanding of pharmaceutical and biotechnology manufacturing processes.
• Familiarity with process validation, equipment qualification, and validation lifecycle activities.
• Experience working with technical documentation and quality systems in regulated environments.
• Working knowledge of Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
• Ability to apply engineering principles and scientific methodologies to manufacturing and process optimization.
• Experience identifying and implementing solutions to technical and operational challenges.
• Strong problem-solving, analytical, and troubleshooting skills.
• Technical report writing and documentation experience.
• Excellent verbal and written communication skills.
• Comprehensive understanding of validation protocol execution and compliance requirements.
• Ability to operate and utilize specialized laboratory equipment, engineering systems, and computerized applications.

Preferred Technical Skills

• Clean Utilities
• GMP Compliance
• Deviation Investigations
• CAPA Management
• Process Optimization
• Manufacturing Support
• Validation and Qualification
• Technical Documentation
• Regulatory Compliance
• Cross-Functional Leadership

Why Join This Opportunity?

This is an excellent opportunity for a seasoned engineering professional to lead high-impact projects, influence strategic engineering initiatives, and contribute to operational excellence within a world-class pharmaceutical or biotechnology manufacturing environment.