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Reliability & Facility Manager - Winston-Salem, United States - Charter Medical Ltd
1 week ago
Description
Charter Medical, LLC is a life sciences company that is committed to designing, developing, and manufacturing quality products to support cell and gene therapy, bioprocessing, and blood management.
The Reliability & Facility Manager is responsible for planning, organizing, and managing the manufacturing facilities and equipment, including the operations systems (HVAC, electrical, etc.); they will also ensure the maintenance personnel and outside contractors perform their work in a safe and compliant manner.
This on-site position is responsible for assisting in the development and management of the facilities expenses and capital budgets.This role will also lead, create, and administer the Metrology/Calibration/Preventative Maintenance (PM) initiatives to effectively increase machine/facility system reliability and compliance.
Job Duties:
Manages the Maintenance team to ensure PM's and all Work orders are maintained and compliant to ISO and normal operations requirements.
Position scope includes equipment, grounds, structure, utilities, and HVAC systems.
Acts as the liaison with facility system's vendors and subject matter expert in assigned areas.
Provides the leadership to supervise contractors, outside service providers and internal maintenance personnel to effectively meet business needs.
Maintains a close and collaborative working relationship with OPS, HSE, and Engineering functions.
Communicates openly and is transparent with progress of work, projects, improvements, and activities to ensure alignment with all departments.
Maintains accurate records of work and changes to facility assets. Ensures facilities are in compliance with QMS including cGMP's, SOP, WI's, Codes, and appropriate safety regulations.
Works closely with internal and external groups to improve equipment efficiency, facility performance, operating cost, and reliability. Develops scopes of work, bids, budgets, and provides project management services for facility related projects and services.
Develops, provides and/or manages training for contractors, maintenance and engineering personnel as needed.
Optimizes and manages the Predictive Maintenance (PdM) Program at the site, which includes vibration analysis, oil analysis, thermography, ultrasonic, and circuit analysis.
Works jointly with the validation team to develop, administer, and maintain validation of measurement and calibration systems.Determines which major systems and components will be maintained on a predictive basis and which will be maintained on an interval-based PM or on-condition basis.
Creates risk mitigation strategies for critical assets.Ensures that the appropriate Maintenance and Reliability metrics are in place throughout the site (asset utilization, planned/unplanned work, equipment cost metrics, replacement asset value, etc.).Identifies staffing requirements, participates in the selection and hiring process; interviews applicants and makes hire recommendations.
Provides coaching, feedback, and guidance to team members on a continual basis and takes an active role in developing, monitoring, and updating a career plan for advancement.
Completes performance appraisals and reviews with employees; recommends salary increases to management and HR.Provides input to the department budgeting process and monitors and controls expenses through the year to meet budget requirements.
Follow Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required, and gowning procedures in designated areas.
Qualifications:
High School diploma or equivalent required.
Specialized training in vibration analysis, thermographic imaging, reliability centered maintenance, preferred.8-12 years of maintenance engineering experience within a regulated manufacturing environment (preferably in an FDA registered site years prior experience in facilities and/or operations in areas of maintenance, process/production procedures, facility management systems and capital project management.- 3 years' experience with facility commissioning and FDA validation requirements.
Strong written and verbal communication skills.
Well organized and capable of organizing the work of others by task assignments.
Documented professional Development in Vibration Analysis, Thermographic Imaging, Reliability Centered Maintenance.
Proficient in MS Office Products, CMMS, and able to learn vendor specific software.
Demonstrated proficiency in creating and providing technical training.
Physical Requirements:
Must be able to perform the essential functions of the job, with or without a reasonable accommodation:Ability to stand/sit/walk frequentlyAbility to use hands to grasp and perform fine manipulation occasionallyAbility to stretch/reach with hands and arms occasionallyAbility to lift arms overhead occasionallyAbility to climb or balance occasionallyAbility to stoop, kneel, crouch or crawl frequentlyAbility to talk or hear frequentlyAbility to lift up to 50lbs occasionallyAbility to push and/or pull occasionallyMay operate forklift occasionally.