Job Title - Senior Process Equipment and Reliability Engineer l Job Location - Cranbury NJ Job Summary The Senior Process Equipment & Reliability Engineer is responsible for supporting and advancing equipment reliability, asset lifecycle management, and maintenance optimization within a biopharmaceutical manufacturing facility. This role serves as a technical leader within the engineering organization, providing expertise in equipment performance, troubleshooting, maintenance strategy, and continuous improvement. The Senior Engineer partners closely with Manufacturing, Maintenance, Quality, Validation, and Process Engineering teams to ensure process and utility equipment operates safely, reliably, and in compliance with cGMP requirements. The position drives asset performance improvements, supports capital projects, and contributes to reliability programs that enhance equipment uptime, product quality, and operational efficiency. Job Responsibilities Leadership & Technical Guidance Provide technical mentorship and guidance to junior engineers, maintenance personnel, and cross-functional teams. Lead reliability-focused initiatives and support implementation of site engineering objectives. Serve as a subject matter expert (SME) for equipment reliability, maintenance optimization, and asset performance. Participate in cross-functional project teams to support manufacturing, capital projects, investigations, and continuous improvement efforts. Support engineering management in developing reliability strategies aligned with business and operational objectives. Equipment Reliability & Performance Apply reliability engineering tools including FMEA, RCFA, RCM, and predictive maintenance methodologies. Lead investigations into equipment failures and recurring issues, implementing effective CAPAs. Analyze equipment performance data and develop strategies to improve uptime, reliability, and maintenance effectiveness. Establish and monitor KPIs including

MTBF, MTTR, PM

compliance, and equipment availability. Support condition monitoring and predictive maintenance programs. Maintenance Strategy & Asset Management Develop and optimize preventive and predictive maintenance strategies. Conduct equipment criticality assessments and risk evaluations. Support spare parts optimization and critical spare identification. Utilize CMMS systems (Maximo, SAP, or equivalent) to manage asset data, maintenance plans, and performance metrics. Contribute to equipment lifecycle planning, replacement strategies, and obsolescence management. Process Equipment Support Provide technical support for troubleshooting, maintenance, and optimization of critical process and utility equipment, including: Bioreactors and fermenters Chromatography and filtration systems Single-use technologies Autoclaves and sterilization equipment Clean utilities (WFI, Clean Steam, Purified Water, Compressed Gases) HVAC and environmental control systems Support equipment commissioning, qualification, validation, startup, and operational readiness activities. Review and provide technical input on equipment modifications, change controls, and engineering projects. Qualifications Bachelor's degree in Mechanical, Chemical, Electrical, Bioprocess, or related Engineering discipline; advanced degree preferred. 5+ years of experience in equipment reliability, maintenance, manufacturing, or process engineering within a cGMP-regulated pharmaceutical or biopharmaceutical environment. Strong knowledge of reliability engineering principles, maintenance optimization, and asset lifecycle management. Experience supporting biologics manufacturing equipment and utility systems. Proficiency with CMMS platforms such as Maximo, SAP PM, or equivalent. Strong troubleshooting, root cause analysis, and problem-solving skills. Demonstrated ability to lead projects and collaborate across multiple functions. Excellent communication and organizational skills. Must be able to wear appropriate PPE, stand/sit/walk for extended periods, climb ladders, and occasionally lift up to 50 lbs. The anticipated salary for this position is $70,000-120,000 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