Senior Process Equipment and Reliability Engineer

Job Title – Senior Process Equipment and Reliability Engineer

Job Location – Cranbury NJ

Job Summary



The Sr. Process Equipment and Reliability Engineer will serve as the technical leader and subject matter expert for equipment reliability and lifecycle management within a biopharmaceutical manufacturing facility. This role is responsible for developing and executing reliability strategies, guiding a team of engineers/technicians, and partnering with cross-functional stakeholders to ensure reliable, compliant, and cost-effective operation of process and utility equipment. The Lead Engineer will drive long-term asset performance improvements while providing day-to-day technical leadership for troubleshooting, maintenance strategy, and continuous improvement initiatives.

Responsibilities:

• Provide leadership, direction, and mentorship to a team of reliability engineers and maintenance professionals.
• Set vision and strategy for the site’s equipment reliability program, aligned with manufacturing goals, compliance standards, and corporate initiatives.
• Develop and maintain equipment lifecycle management plans, balancing performance, cost, and risk.
• Represent Reliability Engineering in cross-functional forums, audits, and regulatory inspections.
• Lead implementation of reliability engineering tools and methodologies (FMEA, RCM, RCFA, Weibull analysis, predictive monitoring).
• Establish and track site-level equipment reliability KPIs, driving accountability and continuous improvement.
• Oversee technical investigations of recurring failures and champion long-term solutions to eliminate systemic issues.
• Ensure reliability initiatives are aligned with business priorities (production schedule, compliance, cost optimization).
• Own the development and optimization of preventive and predictive maintenance programs across the facility.
• Guide criticality assessments to prioritize assets for reliability improvement focus.
• Partner with Supply Chain and Maintenance to ensure spare parts strategy, vendor support, and contracts are aligned with reliability goals.
• Drive adoption of digital and data-driven technologies (e.g., CMMS, condition monitoring, advanced analytics).
• Provide technical leadership for troubleshooting and optimization of critical process equipment, including upstream, downstream, and fill/finish systems (e.g., bioreactors, chromatography skids, filtration units, CIP/SIP systems, autoclaves).
• Collaborate with Process Engineering, Manufacturing Sciences, and Operations to ensure process-equipment fit and reliability.
• Support equipment design, procurement, commissioning, qualification, and validation activities for new installations and modifications.
• Ensure all engineering and reliability activities are compliant with cGMP, FDA, EMA, and other applicable regulatory standards.
• Author, review, and approve technical documentation, SOPs, maintenance procedures, and engineering reports.
• Support responses during regulatory inspections and audits related to equipment and reliability.
  
  
  
  

Continuous Improvement & Culture

• Champion a culture of reliability, safety, and continuous improvement across the site.
• Train and develop staff on equipment reliability principles, tools, and best practices.
• Partner with Quality, Manufacturing, and EHS to identify and execute improvement opportunities.
• Benchmark and adopt industry best practices for biopharma reliability engineering.
• Qualifications:
• Bachelor’s or Master’s degree in Mechanical, Chemical, Bioprocess, or related Engineering discipline.
• 7 years of experience in equipment reliability, process engineering, maintenance, and single-use technology within a regulated biopharma/pharmaceutical manufacturing environment.
• Minimum 1–5 years of demonstrated people-leadership experience (managing engineers, technicians, or cross-functional teams).
• Must be able to wear appropriate PPE, ability to stand /sit/walk for long periods of time, ability to lift 50 lbs. occasionally.
• Strong knowledge of biologics process equipment and cGMP regulatory requirements.
• Proven experience in risk mitigation planning and ability to solve complex manufacturing process engineering-related problems. Ability to make appropriate judgments and rapidly troubleshoot issues to achieve cGMP production operation success
• Proven success implementing reliability methodologies and maintenance strategies at scale.
• Excellent leadership, communication, and team development skills.
• Experience with CMMS systems, asset management practices, and data-driven decision-making.
• Must work in a self-motivated, highly flexible, well-organized, and detail-oriented style with the requirement of some evening conference call time and occasional international travel.
  
  
  
  

The job description does not intend to list all the duties and responsibilities assigned to this position. An employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and the company's business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability