Principal Process Engineer

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. 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 Annex1 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 of mechanical systems, pneumatics, and automation interfaces Experience with CMMS platforms (SAP PM, etc.) Strong understanding of GMP change control and validation impact Ability to interpret Piping and Instrumentation Diagrams (P&IDs), electrical schematics, and Original Equipment Manufacturer (OEM) documentation Knowledge of sterile processing and contamination control principles Technical leadership without direct authority Strong analytical and structured problem‑solving skills Excellent technical writing and documentation skills Ability to influence Maintenance, Quality, and Operations Strong sense of ownership and accountability Ability to balance compliance, reliability, and production demands Physical Requirements Ability to work in GMP cleanroom environments (GradeA/B/C/D) wearing required gowning for extended periods Capable of standing and walking for long durations during production support Ability to climb ladders and access elevated platforms Must be able to lift up to 25lbs (11kg) occasionally Comfortable working in tight mechanical spaces around production equipment Manual dexterity to use tools, instruments, and diagnostic devices Ability to work near moving machinery, steam systems, and hot surfaces with appropriate PPE Medically able to wear respiratory protection if required Willingness to provide off‑hours technical support during critical equipment issues Compensation & Benefits Base salary range: $125,000 to $160,000. Additional compensation includes an annual bonus tied to individual and company performance, and a comprehensive benefits package featuring healthcare (medical, dental, vision), a 401(k) plan with company match, disability and life insurance, wellness programs, tuition reimbursement, paid time off, and paid parental leave. Location Parsippany, New Jersey. Equal Opportunity Employer Ferring is an equal‑opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws. #J-18808-Ljbffr Ferring Holding SA