ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017.
About the job:
The Senior Equipment Specialist reporting to the Sr Manager Engineering is responsible for the maintenance oversight, and lifecycle administration of manufacturing, laboratory, utility, and facility equipment. This role ensures equipment assets are properly documented, maintained, compliant, and optimized to support operational excellence. The Senior Equipment Specialist works closely with Engineering, Facilities, Manufacturing, Quality, Validation, and Procurement teams to ensure equipment performance, regulatory compliance, and asset integrity throughout the equipment lifecycle.
Responsibilities:
Equipment & Asset Lifecycle Management
- Manage equipment assets throughout their lifecycle, including acquisition, installation, commissioning, qualification, maintenance calibration, upgrades, relocation, and retirement.
- Maintain accurate equipment records within the CMMS system.
- Ensure all equipment is properly tagged, classified, and documented.
- Conduct periodic equipment inventories and asset audits.
- Monitor equipment utilization and identify opportunities for optimization and cost reduction.
Maintenance & Reliability
- Coordinate preventive and predictive maintenance activities to maximize equipment uptime and reliability.
- Review equipment performance and maintenance history to identify recurring issues and improvement opportunities.
- Initiate and support deviations , root cause investigations and corrective actions for equipment failures.
- Monitor reliability metrics including MTBF, MTTR, and equipment availability.
- Collaborate with maintenance and engineering teams to improve asset performance and lifecycle value.
Compliance & Documentation
- Ensure equipment documentation is complete, accurate, and audit-ready.
- Maintain equipment files, SOPs, maintenance records, calibration records, and qualification documentation.
- Support compliance with GMP, FDA, OSHA, ISO, and company quality requirements.
- Participate in internal and external regulatory audits and inspections.
Equipment Projects & Technical Support
- Support equipment installation, qualification, validation, and startup activities.
- Participate in capital projects involving new equipment procurement and implementation.
- Assist in evaluating equipment vendors, service providers, and maintenance contractors.
- Coordinate equipment upgrades, modifications, and replacement initiatives.
Asset Data & Reporting
- Generate and analyze equipment performance reports and KPIs.
- Track maintenance compliance, downtime trends, and equipment reliability metrics.
- Develop recommendations for equipment replacement, refurbishment, and lifecycle planning.
- Support annual budgeting and capital planning activities.
Cross-Functional Collaboration
- Partner with Engineering, Operations, Quality, Validation, Facilities, and Procurement to support business objectives.
- Provide technical guidance related to equipment management processes.
- Support continuous improvement initiatives focused on equipment reliability, maintenance effectiveness, and operational efficiency.
Qualifications:
- Bachelor's degree in Engineering, Industrial Technology, Mechanical Engineering, Electrical Engineering, Facilities Management, or a related technical discipline.
- Equivalent combination of education and relevant experience may be considered.
- Minimum 5+ years of experience in equipment management, maintenance, reliability engineering, facilities engineering, manufacturing engineering, or related functions.
- Experience managing equipment assets within CMMS systems.
- Proficiency with CMMS (SAP PM, Maximo, Infor, Fiix, UpKeep, or similar systems).
- Strong working knowledge of equipment maintenance and lifecycle management practices.
- Understanding of equipment qualification, calibration, and validation requirements.
- Advanced Microsoft Excel and reporting capabilities.
- Familiarity with reliability-centered maintenance and continuous improvement methodologies.
- Experience in pharmaceutical, biotechnology, biologics, medical device, or other regulated manufacturing environments. (Preferred)
- Knowledge of GMP, FDA, ICH, and ISO requirements. (Preferred)
- Experience supporting commissioning, qualification, and validation activities (Preferred)
The estimated pay range for the role is between $95,000 - $125,000 depending on experience and skill set
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Benefits:
Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
ProBio Inc. maintains a drug-free workplace.
Please note: ProBio Inc. will only contact candidates through verified application sources. Probio does not request personal information from candidates through individual email or any other platform.