Equipment Maintenance Reliability Engineer

WuXi AppTec•Middletown, DE

About The Position

We are seeking a skilled and experienced Equipment Maintenance & Reliability Engineer to support the maintenance, repair, and reliability of base building and manufacturing equipment in our pharmaceutical manufacturing facility. This role is responsible for ensuring all equipment, automation & controls, utilities, and facilities are operated efficiently, safely, and maintained in compliance with Good Manufacturing Practices (GMP), FDA, and other regulatory standards . The ideal candidate will support the cGMP Maintenance & Controls Manager and the Utilities Superintendent to implement cGMP compliant preventive/predictive maintenance programs, while working closely with cross-functional teams to support production goals and continuous improvement initiatives.

Requirements

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
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
Must be able to work in an office environment with minimal noise conditions
Must be able to wear appropriate PPE
Must be able to work in an environment with variable noise levels
Ability to stand/sit/walk for long periods of time
Ability to lift 10 lbs. routinely
Ability to crouch, bend, twist, and reach
Ability to push/pull 10 lbs. routinely / often / occasionally
Clarity of vision
Ability to identify and distinguish colors
Must be able to perform activities with repetitive motions
Ability to climb ladders / stairs / scaffolding
Ability to work in variable temperatures (hot, cold, etc.)
Ability to work both inside and outside in varying working conditions

Nice To Haves

Certification in Lean Manufacturing, Six Sigma, or Reliability-Centered Maintenance (RCM).
Control automation and PLC experience is a plus

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 recordkeeping 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