Job Title: Principal Engineer – Biotechnology Industry
Reference ID: 3561394
Work Schedule: Hybrid/Remote – Administrative Shift
Location: Open to Puerto Rico Residents
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
If you are interested in this opportunity and meet the qualifications listed above, we encourage you to apply by submitting your updated resume for consideration.