We are seeking a skilled and experienced Maintenance Manager to oversee the maintenance, repair, and reliability of base building and manufacturing equipment in our pharmaceutical manufacturing facility. This role is responsible for ensuring all equipment, 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 lead a team of maintenance technicians and engineers, implement preventive maintenance programs, while working closely with cross-functional teams to support production goals and continuous improvement initiatives.
Responsibilities Maintenance Operations & Equipment ReliabilityOversee the maintenance, repair, and servicing of pharmaceutical manufacturing equipment, utilities, and facility infrastructure.Develop and implement preventive and predictive maintenance programs to minimize downtime and improve equipment performance.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 & DocumentationMaintain accurate records of maintenance activities, work orders, SOPs, calibration, and validation reports.Ensure all equipment and systems are properly qualified and validated per regulatory standards.Participate in audits and regulatory inspections, providing necessary maintenance documentation and reports.Team Leadership & TrainingLead and manage a team of maintenance technicians, providing training and development opportunities.Foster a culture of safety, quality, and continuous improvement within the maintenance department.Collaborate with cross-functional teams, including Production, Quality Assurance, Engineering, and Safety teams.Continuous Improvement & Cost ManagementIdentify and implement efficiency improvements to optimize maintenance operations and reduce costs.Manage the maintenance budget, spare parts inventory, and vendor contracts to ensure cost-effective maintenance solutions.Recommend and implement energy-saving and sustainability initiatives to improve facility performance. Qualifications Strong knowledge of GMP, FDA, OSHA, and industry best practices in equipment maintenance.Hands-on experience with HVAC systems, water purification, sterile processing, calibration, and automation systems.Experience with Computerized Maintenance Management Systems (CMMS).Excellent problem-solving, leadership, and project management skills.Ability to work in a fast-paced, highly regulated environment.
Preferred Qualifications:
Certification in Lean Manufacturing, Six Sigma, or Reliability-Centered Maintenance (RCM).Knowledge of PLC, SCADA, and Building Management Systems (BMS).
Experience / Education
Bachelor’s degree in engineering (Mechanical, Electrical, Industrial) or a related field.5+ years of maintenance experience in a pharmaceutical, biotechnology, life science, or FDA-regulated manufacturing environment.
Knowledge / Skills / Abilities:
Strong hands on leadership style Proficient in oral & written communication skillsDemonstrated ability to read, write and speak English Proficient in Microsoft Office (Excel, Word, Outlook) 20% travel is required; both domestic and international
Physical Requirements:
Must be able to work in an office environment with minimal noise conditionsMust be able to wear appropriate PPEMust be able to work in an environment with variable noise levelsAbility to stand/sit/walk for long periods of time Ability to lift 10 lbs. routinelyAbility to crouch, bend, twist, and reachAbility to push/pull 10 lbs. routinely / often / occasionallyClarity of visionAbility to identify and distinguish colorsMust be able to perform activities with repetitive motionsAbility to climb ladders / stairs / scaffoldingAbility 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.
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