Job Description
Job Description
The Principal Engineer manages and applies extensive technical expertise in coordinating multiple, complex, and non-routine engineering projects involving the planning, design, reconfiguration, construction, maintenance, and optimization of systems, facilities, and processes. This position employs deep technical knowledge across multiple engineering disciplines—such as process engineering, unit operations, and equipment projects—to support process characterization, optimization, scale-up, and manufacturing operations.
Key Responsibilities
- Establish and enforce engineering policies and standards for major business segments.
- Interpret, execute, and recommend modifications to company-wide engineering policies and best practices.
- Develop and manage organizational or project budgets encompassing multiple engineering disciplines for large-scale or complex initiatives.
- Apply advanced engineering theories, principles, and methodologies to develop innovative concepts and technical solutions.
- Conduct in-depth investigations and research to define project scope, identify improvement areas, and develop novel engineering approaches.
- Lead cross-functional teams consisting of engineers, technicians, and subject matter experts to plan, coordinate, and execute complex projects.
- Collaborate with manufacturing, process development, research, utilities, facilities, quality assurance, and validation teams to define system and process requirements.
- Design, implement, and execute engineering or process projects that contribute significantly to achieving key organizational objectives.
- Serve as a corporate engineering resource, specializing in multiple engineering domains and providing technical leadership.
- Drive continuous improvement initiatives focused on process optimization, reliability, and performance enhancement.
- Ensure all work complies with GMP/GLP, regulatory, and corporate engineering standards.
- Perform other duties as assigned to support business and operational needs.
Competencies & Skills
- Strong working knowledge of pharmaceutical or biotech manufacturing processes.
- Familiarity with validation processes, documentation, and regulated industry standards.
- Ability to apply engineering science and problem-solving techniques to production environments.
- Proficient in technical report writing, root cause analysis, and verbal communication.
- Skilled in operating specialized laboratory and production equipment and interpreting GLP/GMP requirements.
- Comprehensive understanding of validation protocol execution and regulatory documentation.
- Capable of managing complex, cross-functional projects and coordinating multiple stakeholders.
Requirements
Education & Experience
- Doctorate in Engineering with 2+ years of experience, OR
- Master’s Degree in Engineering with 4+ years of experience, OR
- Bachelor’s Degree in Engineering with 6+ years of experience.
Preferred Qualifications
- Demonstrated experience applying reliability engineering methodologies (e.g., FMEA, RCM, RCA, Weibull analysis, predictive analytics) to enhance equipment and system performance.
- Proven ability to manage and interpret equipment reliability metrics (e.g., MTBF, MTTR, OEE) to drive data-driven process improvements.
- Professional certification(s) such as CMRP, CRE, or PE preferred.
- Success in implementing asset reliability and performance programs in manufacturing environments.
- Hands-on experience with CMMS and reliability or predictive maintenance tools such as Maximo, SAP, XFRACAS, or ReliaSoft.
- Excellent analytical, problem-solving, and data interpretation skills, with the ability to translate complex data into actionable insights.
- Strong leadership and communication skills with the ability to influence across organizational levels.
Benefits
- 1 year contract