Principal Process Engineer

Responsibilities

• Reliability Lead
• Own and lead the reliability strategy for all critical assets supporting aseptic manufacturing
• Establish reliability standards, methodologies, and best practices
• Serve as the technical authority for reliability engineering and failure analysis
• Mentor maintenance and engineering team members on reliability principles
• Asset Criticality & Maintenance Optimization
• Develop and maintain asset criticality rankings based on: Sterility risk
• Patient safety impact
• Production continuity
• Regulatory risk
• Lead Reliability Centered Maintenance (RCM) and Failure Modes and Effects Analysis (FMEA) programs
• Optimize preventive and predictive maintenance strategies to reduce reactive work
• Drive preventive maintenance (PM) optimization using failure history and condition-monitoring data
• Advanced Failure Analysis & Defect Elimination
• Lead complex Root Cause Failure Analyses (RCFA) for: Chronic equipment failures
• Major line stoppages
• Equipment issues with potential sterility or quality impact
• Apply advanced reliability tools such as: Weibull analysis
• MTBF / MTTR modeling
• Reliability growth analysis
• Implement sustainable corrective actions and verify effectiveness
• Predictive & Condition-Based Maintenance Programs
• Expand and manage predictive technologies including: Vibration monitoring
• Infrared thermography
• Ultrasound inspection
• Lubrication and oil analysis (where applicable)
• Define monitoring strategies for critical rotating and sterile-process equipment
• Transition equipment from time-based to condition-based maintenance where appropriate
• GMP, Sterility & Regulatory Support
• Ensure reliability improvements maintain the validated state of GMP equipment
• Assess reliability-related changes for validation and quality impact
• Support deviation investigations, CAPAs, and change control processes
• Participate in contamination control and risk assessments for aseptic systems
• Serve as an engineering SME during regulatory inspections and audits
• Ensure alignment with FDA, EU Annex 1 expectations
• Capital Projects & Lifecycle Management
• Provide reliability input during: Equipment design reviews
• FAT/SAT
• Commissioning and qualification
• Drive design-for-reliability improvements for new systems
• Lead obsolescence management and long-term asset replacement planning
• Support spare parts strategy based on reliability risk
• Data, Systems & Performance Metrics
• Use CMMS and reliability tools to analyze equipment history and trends
• Develop dashboards for: MTBF, MTTR
• Equipment availability
• Maintenance cost vs. reliability performance
• Present reliability performance and improvement plan to site leadership

Requirements

• Bachelor's degree in mechanical, electrical, industrial, or reliability engineering
• Master's degree in Engineering or Reliability Engineering (preferred)
• 8+ years of engineering experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments
• 5+ years in reliability, maintenance, or asset engineering roles
• Direct experience with aseptic or sterile pharmaceutical manufacturing equipment strongly preferred
• Experience with clean utilities (WFI, clean steam, compressed gases) and classified HVAC systems
• Demonstrated experience leading cross-functional technical investigations
• Deep knowledge of: Reliability engineering methodologies (RCM, FMEA, RCFA)
• Predictive and condition-based maintenance
• Mechanical systems, pneumatics, and automation interfaces
• Experie

Benefits

Additional Information

Job Description: As a privately- owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease. The Principal Process Engineer is the technical lead for equipment reliability and asset performance. This role drives reliability strategy, failure elimination, and lifecycle optimization for equipment used in sterile pharmaceutical manufacturing. This position ensures high asset availability while maintaining full compliance with GMP, sterility assurance, and regulatory requirements. This is an individual contributor role with broad cross-functional influence across Maintenance, Manufacturing, Quality, Validation, and Engineering. With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

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