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.

Maintenance Operations & Equipment/Controls Reliability

• 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.

Regulatory Compliance & Documentation

• 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

Team Leadership & Training

• 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.

Continuous Improvement & Cost Management

• 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

Required Qualifications:

• 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

Preferred Qualifications:

• Certification in Lean Manufacturing, Six Sigma, or Reliability-Centered Maintenance (RCM).

Experience / Education       

• 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.

Knowledge / Skills / Abilities:

• 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

Physical Requirements:               

• 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

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

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.