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.

The Principal Reliability 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.

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

• 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 (Grade A/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 25 lbs (11 kg) 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

Role will be in Parsippany, NJ.

Ferring + you

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.

Our Compensation and Benefits

At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $125,000 to $175,000, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.

Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 15 paid holidays per year. We are proud to offer paid parental leave subject to a minimum period of employment at Ferring.

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, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.

Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.

We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.

Location:

Parsippany, New Jersey