WuXi Chemistry · 7 hours ago
Equipment Maintenance Reliability Engineer
Middletown, DE
Full-time
Onsite
Senior Level
5+ years expWuXi Chemistry is a pharmaceutical manufacturing facility seeking a skilled Equipment Maintenance & Reliability Engineer. This role is responsible for supporting the maintenance and reliability of equipment, ensuring compliance with regulatory standards, and implementing preventive maintenance programs while collaborating with cross-functional teams.
Pharmaceuticals
Hiring Manager
Alice Riggs, CPC
Responsibilities
Support the installation, testing, and commissioning of equipment systems to ensure proper functionality and performance
Support the maintenance, repair, and servicing of pharmaceutical manufacturing equipment, automation & controls, clean utilities, and facility infrastructure
Assist in the development and implementation of both cGMP and non-GMP preventive maintenance programs to minimize downtime and improve equipment/system performance
Develop and implement a comprehensive Predictive Maintenance program including electrical system thermography, vibration analysis, and oil sampling
Ensure compliance with GMP, FDA, OSHA, and other regulatory requirements for maintenance activities
Implement root cause analysis (RCA) and corrective action plans for equipment failures
Maintain accurate records of maintenance activities, work orders, SOPs, calibration, and validation reports
Ensure all equipment and systems are properly qualified and validated by regulatory standards
Participate in audits and regulatory inspections, providing necessary maintenance documentation and reports
Responsible for emissions control equipment (RTO) and Title V Air Permit reporting
Responsible for site drawing change control & management program
Manage the regulatory testing program for the emergency diesel generators, the diesel fire pumps, and other critical life safety equipment
Provide technical support and guidance to operations and maintenance personnel including training on equipment operation and maintenance
Foster a culture of safety, quality, and continuous improvement within the Maintenance department
Collaborate with cross-functional teams, including Production, Quality Assurance, Quality Control, Supply Chain, Engineering, and Safety teams
Identify and implement efficiency improvements to optimize maintenance operations and reduce costs
Assist with the management of the maintenance budget, the spare parts inventory, and vendor service contracts to ensure cost-effective maintenance solutions
Recommend and implement energy-saving and sustainability initiatives to improve facility performance
Track facilities operations to uphold contracts for repairs and maintenance, trash disposal & recycling, pest control, security vendors, janitorial services as applicable
Maintain site security/video surveillance by providing door access controls and ensuring proper staff and visitor access procedures are followed
Assist with the management of the instrumentation calibration and preventative maintenance program for all GMP equipment, clean utilities, lab equipment including compressed gases, HVAC systems, electrical, life safety, and emergency power systems (UPS)
Organize and manage record keeping of preventative maintenance, instrument calibrations, facilities cleaning activities according to cGMP/GLP requirements
Maintain up to date records for all state, federal, and local licenses and inspections
Conduct small to medium capital projects from conception to construction
Develop and manage overall department performance KPI’s and leadership reporting
Qualification
Required
Strong knowledge of GMP, FDA, OSHA, and industry best practices in equipment maintenance
Hands-on experience with cleanrooms, HVAC systems, water purification, compressed air, sterile processing, electrical systems, pressure/temperature/flow instrumentation, instrumentation testing & calibration, and automation systems
Knowledge of PLC's, HMI's, SCADA, Building Management Systems (BMS), and Environmental Management Systems (EMS)
Experience with Computerized Maintenance Management Systems (CMMS) – past experience with SAP R/4 HANA EAM module is a definite plus
Control automation and PLC experience is a plus
Comfortable writing department operational/maintenance SOPs
Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Industrial) or a related field
Minimum of 5+ years of maintenance/reliability experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment
Strong hands-on leadership style
Excellent problem-solving, leadership, and project management skills
Proficient in oral & written communication skills
Experience with AutoCAD or other drawing management system is required
Proficiency in Microsoft Office (Excel, Word, Outlook, PowerPoint)
Self-motivated, high-energy level and a positive outlook coupled with a can do attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Preferred
Certification in Lean Manufacturing, Six Sigma, or Reliability-Centered Maintenance (RCM)
Company
WuXi Chemistry
WuXi Chemistry, a business division of WuXi AppTec, provides contract services for new drug development from discovery to commercial.
10001+ employees
H1B Sponsorship
WuXi Chemistry has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (1)
Funding
Current Stage
Late StageRecent News
GlobeNewswire News Room
2025-02-25
Company data provided by crunchbase