SUMMARY We are seeking a highly motivated technical expert to lead the Maintenance Department for Inspection & Packaging Area a Non Standard shift Organization. The Maintenance Manager will ensure production equipment operates safely and efficiently. As a maintenance manager, be highly motivated and function effectively as a leader and mentor. We are seeking highly organized and detail-oriented candidates, with strong multi-tasking and time-management skills. The Maintenance Manager plans, directs, and controls the efforts of the maintenance department to maintain inspection and packaging equipment complying with recognized best engineering and maintenance practices. Several positions available SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Accountable for the preventive maintenance program, and maintenance of production equipment and facility. Develops and, trains maintenance workforce to assure the team is performing at a high level of performance. Responsible to maintain all equipment and facilities in top condition and operating in a safe manner Executes an effective preventive maintenance program to minimize unscheduled down time. Schedules needed repairs to have minimum interference. Assist in coordinating planned equipment outages and standard downturns. Assures that production equipment is capable of producing within the specifications and tolerances established by the equipment manufacturer. Analyze equipment needs, ensure equipment reliability, and develop PPM programs, including maintenance trending charts. Manage equipment troubleshooting, repairs, root cause analysis, and equipment improvements. Consults with peers and manufacturing management regarding planned modifications of existing equipment and facilities and the possible replacement of existing equipment with the goal of improving equipment operation and reduce maintenance costs. Develops objectives and standards of performance for projects within the maintenance department required to meet departmental and corporate goals and objectives. Plans and provides for an adequate supply and ensures control over spare parts and maintenance supplies. Oversees department budget and ensures all work completed is within budget parameters. Keeps and updates equipment and facility records and procedures; such as equipment manuals, schematic drawings, and facility drawings. Ensures that all equipment and facility installations and/or modifications meet or exceed all regulatory agency i.e. (USDA, FDA, OSHA, ADA, EPA) standards and complies with all Company policies and/or procedures. Adheres to all quality policies and procedures, reporting any nonconformity. Adheres to all safety policies and procedures, reporting any nonconformity. Adheres to all GMP policies and procedures, reporting any nonconformity. Support internal and external Audits with different agencies. Perform other duties as required or assigned by management. EDUCATION/LICENSES Bachelor's degree in Engineering & 5 years of maintenance experience in a GMP environment OR Master's degree in Engineering & 3 years of maintenance experience in a GMP environment OR Doctorate degree in Engineering AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources PREFERRED QUALIFICATIONS Educational Background in Mechanical or Electrical Engineering Availability for Non Standard Shifts Balance of the technical, human relations, and conceptual skills required to achieve results through subordinate supervision. 6+ years of experience in maintenance supervision and management in the pharmaceutical / bio pharmaceutical industry. Significant experience operating and maintaining inspection and packaging equipment. . 3+ years' experience supervising technical staff in a regulated environment. Capable of evaluating and weighing alternatives, establishing relative priorities, and formulating decisions that affect all phases of the operation. Ability to work in a high-pressure environment. Ability to be flexible in the line of work. Lead, guide and teach maintenance staff. Purchase supplies as needed for maintenance projects. Maintains work areas in clean and orderly conditions. Remain calm, patient and polite if receiving customer feedback. Knowledgeable of instrumentation systems including troubleshooting, configuration, installation, documentation, checkout, and commissioning of inspection and packaging equipment instrumentation, sensor and control systems Significant experience with CMMS and multiple maintenance types (Preventive Maintenance/ Predictive Maintenance / Meter Based Maintenance) Familiarity with validation processes and cGMP documentation. Familiarity with calibration processes Familiarity with the safe operation of tool shop equipment . Experience with PLC and Distributed Control Systems Experience maintaining Automatic Visual Inspection systems and equipment for vials and syringes Leadership and team building skills. Excellent verbal and oral communication. Ability to resolve conflicts. Ability to make disciplined decisions. Knowledge of staff relations with the ability to coach mentors and counsels staff when needed. Good organizational skills. Ability to deal with and manage change. Knowledge of basic compensation system practices and methodologies. Strong computer knowledge.
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