The Equipment and Maintenance Manager provides leadership, coordination and management of production equipment maintenance team and plant engineering projects in the manufacturing and processing areas. This position is responsible for the daily interaction and management of the maintenance program and on-site maintenance team in a cGMP operations and manufacturing facility. Project management will also be a key responsibility from a design, planning, implementation, delivery, & qualification perspective. The person will be responsible for managing project timelines, communicating both at a working team level up to senior leadership maintaining a list of project justifications, risks and mitigations, facilitating team meetings and executing project in a timely and cost-effective manner. This position leads, participates, coordinates and executes technical optimization projects within the manufacturing areas and oversees ongoing maintenance of the manufacturing equipment and related systems. including, compressed air systems, boilers, HVAC and BAS systems, heating and cooling systems, control systems serving and including manufacturing and packaging equipment while complying with all federal, state and local laws and regulatory / cGMP guidelines, standards, and policies.
Major Job Accountabilities and Responsibilities
- Team leader of maintenance team
- Multiple project planning, design, tracking and execution
- Loss elimination, risk management and life cycle asset management
- Lead maintenance improvement program to instill an environment of continuous improvement
- Design, create & maintain maintenance owned systems specifications for manufacturing equipment
- Support all design, installation, commissioning, qualification, training activities for manufacturing equipment
- Provide additional technical support to plant project team as required
- Adhere to all regulatory, quality & environmental regulations within area of responsibility
- Establish & manage standards for procedures & maintenance plans
- All safety & environmental requirements in the performance of duties
- Plan, execute and manage for a variety of maintenance and production support equipment requiring a thorough understanding of machinery as well as interpretation of manufacturing equipment and processes.
- Lead maintenance team to ensure that equipment is performing effectively and efficiently and confirming that the equipment, when it is running, is at design speed and capacity.
- Develops, drives, and monitors programs for critical equipment analysis and condition monitoring techniques to promote a strong preventive maintenance program reducing and controlling reactive work orders.
- Explores deficiencies noted during preventive maintenance and reactive data reviews to identify solutions to opportunities to prevent problem recurrence.
- Provides technical guidance for CMMS usage and further development by reviewing and analyzing the work order in collaboration with the Maintenance Supervisor.
- Evaluate troubleshooting capabilities of the maintenance team and develop plans for training to improve and track improvements for team member growth and development.
- Provide feedback to the maintenance personnel regarding equipment condition and plan remediation activities.
- Consults with maintenance technician on technical problems for advanced troubleshooting.
- Monitors shop qualifications and quality standards for outside contractors related to manufacturing equipment maintenance.
- Develops standards and guidelines for major maintenance overhauls and outages.
- Provides leadership and technical guidance for the preventive and predictive maintenance programs.
- Manage equipment projects including, but not limited to writing/reviewing specification, design reviews; equipment installation; commissioning & qualifications.
- Compile and review independent studies of equipment function and malfunctions to support equipment replacement and periodic service scheduling.
- Develop improvements upon existing technology and methods, acting unilaterally with Engineering, or with others, and make recommendations for equipment improvements.
- Organize and coordinate repair work with OEM’s and contractors for projects and equipment repair and improvements.
- Works as a project engineer to ensure the reliability and maintainability of new and existing installations.
- Responsible for administering the life cycle asset management process and applying those principles to all site assets.
- Engage and remain current with cGMP requirements for pharmaceutical facilities, lead and train the maintenance team and guide the in GMP initiatives.
- Standard Operating Procedure (SOP) development; maintenance development & training management of cost, quality & schedule within area of responsibility; establishing & maintain positive working relationship with cross functional groups and within the engineering team
- Responsible to manage maintenance and production areas in a safe, clean and orderly condition according to cGMP documentation.
- All activities are aligned with environmental health & safety (EHS) program requirements.
- Perform all other related duties as requested.
- Ensures department goals are aligned with plant business imperatives.
- Ensures performance goals are met.
- Establishes and ensures achievement of all unit key performance indicators (KPIs).
- Monitor OEE performance indicators and utilize to direct maintenance plans.
- Ensures compliance with corporate standards (e.g., financial, code of business conduct) and adherence to company policies.
- MTTR (Mean time to repair)
- # of achieved cost reductions
- Maintenance planned budget/actual budget (%)
- Promotes open and honest communication.
- Fosters “team building.”
- Fosters a culture focused on problem solving and process improvement.
- Ensures decision making at proper levels.
- Ensures clear roles and responsibilities.
- Determines resource planning and deployment strategy.
- Fosters culture that values diversity and promotes respect, inclusion, cooperation and responsibility.
Minimum Education and Experience Requirements
- Bachelor of Science degree in related engineering field of study with 4 years minimum experience or Associates degree in Engineering/Science related field of study with 8 plus years of experience.
- Additional college credited courses and certifications a plus.
- 5 - 10+ years engineering/ production maintenance experience in a manufacturing facility.
- Knowledge & experience in the operations, maintenance & design of cGMP type equipment as well as working in a regulated environment such as Food & Drug Administration (FDA), Current Good Manufacturing Practice (cGMP) and OSHA
- Knowledgeable in utilities systems to include chilled water, plant steam, compressed air, vacuum, power distribution.
- Understanding of technical documents such as URS, DS, SAT, FAT and Validation Protocols.
- Ability to read, write, and develop preventative maintenance and calibration procedures, logbook entries, work orders, and to perform IQ's and OQ's.
- Ability to plan, manage and coordinate installation activities of new equipment with production and maintenance personnel.
- Must have accomplished knowledge in the following areas with concentrated knowledge in one of them:
- Electrical control systems
- Pneumatic control systems
- Calibrations systems
- Welding - SS/High purity systems
- Machining systems
- Electro-mechanical systems
- Fluid Systems
- Computer systems
- Understanding of complicated product documentation & standard operating procedures with attention to high level concepts
- Computer literacy with equipment and machinery associated systems.
- Proven expertise in planning/organization/execution of project & maintenance activities, following up to ensure results driven performance.
- Revising the work plan for complex problems being resolved by cross functional teams.
Key Interfaces with Other Departments
- This role will be required to interface with intradepartmental business partners including: Manufacturing, Quality, Validation and Finance.
Special Working Conditions/Physical Requirements
- Requires ability to move throughout the facility and equipment in the performance of duties in proximity of facilities and process equipment.
- Ability to work hours necessary & according to plant needs.