Pricipal Engineer (Biotechnology Industry) 3561394

ProQuality Network; United States; Hybrid; USD 140,000 - 180,000; Full time

Job summary

ProQuality Network seeks a highly qualified Principal Engineer in the biotechnology industry to lead complex projects in a regulated manufacturing environment.

The role requires extensive engineering expertise across planning, design, construction, maintenance, and optimization of systems and processes. Strong GMP/GLP documentation and critical operations experience are essential for success.

Qualifications

• PhD, MS, or BS in Engineering with relevant experience.
• Experience in clean utility and gas systems is implied by role.
• Strong documentation and GMP/GLP awareness is essential.

Responsibilities

• Establish engineering policies and provide technical leadership for major operations segments.
• Coordinate budgets for complex engineering initiatives and ensure alignment with manufacturing objectives.
• Lead engineering projects and coordinate cross-functional teams including manufacturing, quality, and validation.

Skills

Problem solving

Technical report writing

Verbal and written communication

Applied engineering

Education

Doctorate degree in Engineering

Master’s degree in Engineering

Bachelor’s degree in Engineering

Job description

Pricipal Engineer (Biotechnology Industry) 3561394

Job Title: Principal Engineer – Biotechnology Industry

Reference ID: 3561394

Work Schedule: Hybrid/Remote – Administrative Shift

Positions Available: 1

Contract Duration: Approximately 1-year contract through ProQuality Network

Job Description

Position Summary

Our client in the biotechnology industry is seeking a highly qualified Principal Engineer to support complex engineering projects in a regulated manufacturing environment.

This role requires extensive technical expertise to lead and coordinate engineering projects related to the planning, design, reconfiguration, construction, maintenance, and optimization of systems, facilities, and manufacturing processes.

The selected candidate will apply advanced knowledge across multiple engineering disciplines to support process characterization, optimization, scale-up activities, and manufacturing operations while ensuring compliance with regulatory and quality standards.

Preferred Qualifications

• Bachelor’s, Master’s, or Doctorate degree in Mechanical Engineering or Chemical Engineering
• Experience working with Clean Utility Systems, including:
• Distilled Water Systems
• Purified Water Systems
• Reverse Osmosis (RO) Systems
• Experience working with Clean Gas Systems, including:
• Process Air
• GMP gas supply systems such as Oxygen and Nitrogen
• Experience documenting and managing Deviations / Non-Conformance investigations
• Proficiency with GMP documentation practices and SOP process improvement
• Experience working in critical operations and capital project environments
• Working knowledge of biotechnology or pharmaceutical manufacturing processes

Additional Technical Skills

• Familiarity with validation processes
• Experience working in highly regulated environments
• Ability to interpret and apply GLPs and GMPs
• Ability to apply engineering science to manufacturing and production operations
• Ability to develop solutions to routine technical problems of limited scope
• Ability to operate specialized laboratory equipment and computerized systems when required
• Strong skills in:
• Problem solving and applied engineering
• Technical report writing
• Verbal and written communication
• Comprehensive understanding of validation protocol execution requirements

Key Responsibilities

• Establish engineering policies and provide technical leadership for major operational segments
• Interpret, execute, and recommend improvements to company engineering policies
• Develop and manage organizational or project budgets for complex engineering initiatives
• Apply advanced technical principles and engineering concepts in the development of new technologies and solutions
• Perform in-depth investigations to define project scope and develop innovative engineering approaches
• Conduct engineering research and technical investigations involving complex systems or processes
• Plan, organize, and coordinate the work of engineers and technical personnel
• Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams
• Develop engineering requirements and recommendations for large-scale or complex system and facility modifications
• Design, execute, and lead engineering projects that contribute to strategic operational and manufacturing objectives

Education Requirements

Candidates must meet one of the following combinations of education and experience:

• Doctorate degree in Engineering with 2+ years of relevant experience, OR
• Master’s degree in Engineering with 4+ years of relevant experience, OR
• Bachelor’s degree in Engineering with 6+ years of relevant experience