Global CMMS Manager on the Uber Account

Responsible for the operation, accuracy and implementation of the computerized maintenance system for the CBRE/Cisco San Jose Campus. Manage the CMMS for assigned campus and ensure inventory of assets is correct, appropriate maintenance tasks are associated with each piece of critical equipment and that the system schedules the work as desired. Schedule preventative maintenance tasks to the appropriately qualified maintenance staff member to increase wrench time as well as minimal disruption to building services.Directly supervise 3 Facility Coordinators that support the Facilities Team.

Self-employed performing technical writing and webdesign.

Identified User Requirements Specification and developed Functional Requirements Specification based on the URS. Defined CMMS User Security levels and tested configurations. Identified and configured required database and screen applications. Performed data field mapping to ensure system data migration integrity. Developed IQ/OQ/PQ documents, process workflow, data entry, data migration and Maximo system validation test scripts for Part 11 and QA compliance.

Coordinated all GMP repair, preventive maintenance and calibration work order acitivities for Manufacturing and Facilities equipment using Pilgrim CMMS and Archibus. Assigned and managed daily work requests. Created, tracked, and routed Equipment Change Orders (ECOs). Updated department SOPs and drawings as appropriate to ensure compliance and system integrity. Trained new CMMS users at all levels as required. Managed and routed Prodagio invoices for approval. Managed outside vendors and gathered all requirements for annual Purchase Order / contracts. Composed deviations and preventive actions when noted and entered into FileMaker database. Followed up on CAPA requirements through full life-cycle completion.

Completed ground-up implementation and validation of Pilgrim CMMS system. Responsible for development all training materials (Manager/QA, Supervisor, Technician) and training all employees and contractors (approximately 80 users). Completed input of calibration Asset records into implemented CMMS system. Routed Job Plan procedures for electronic review. Scheduled Preventive Maintenance and Calibration records accordingly. Responsible for maintaining all GMP documents and providing records for QA/FDA review. Initiated deviation reports when appropriate and helped to determine root cause and impact to production. Routed reports for appropriate department review. Updated department SOPs when required to ensure compliance and system integrity. Routed for review through Doc Control CMMS module. Managed Archibus work request system. Generated all monthly PMs and tracked for completion. Assigned and managed daily work requests. Tracked all department (employee and contractor) training records and assigned employee training based on job function. Created, tracked and routed Equipment Change Orders (ECOs). Updated SOPs and drawings as appropriate to ensure compliance and system integrity. Emergency Response Team Member.

Investigated Out-Of-Tolerance (OOT) calibrations and determined if the OOT caused an impact to client product. Documented findings and reported to QA management for review.

Performed cleaning validation services on pharmaceutical production equipment. Took swab and rinse samples for protein analysis. Compiled cleaning validation data for management review.

Completed ground-up implementation and validation (commissioning, IQ/OQ/PQ) of MAXIMO CMMS six months ahead of schedule and $250,000 under budget. Responsible for developing, implementing, and revising operational, PM, and administrative SOPs. Master Scheduler for Facilities Operations working with Validation, QA, Clinical and Commercial Production, Calibration, Spare Parts, and Information Systems to coordinate monthly maintenance and semi-annual facilities shutdown maintenance. Working closely with these groups helped to reduce and in some cases eliminate production down-time. Initiated and completed utility shutdown packages which involved QA and Validation approval to ensure maintenance performed on utility systems were in compliance with approved SOPs and did not effect validation change control. Reviewed completed preventive and emergency maintenance work orders for compliance with cGMPs. Initiated deviation/exception reports when appropriate. Determined root cause and appropriate corrective action. Responsible for tracking and follow-through to completion. Managed facilities P&IDs per FDA requirements which included walk-down of the drawings and updating as required. Directly interacted with FDA regulating agencies and European agencies during regulatory audits. Responsible for Facilities metrics reporting including equipment and production down-time, unplanned maintenance, and potential product impacting breakdowns. Direct supervisor of two employees.

Ensure ongoing MAXIMO CMMS integrity, checking, creating/closing work orders and PMs. Responsible for training of new and existing users. Maintain current MAXIMO SOP standards to cGMP and FDA requirements. Create management and tracking reports using SQR and Visual SQRibe. Key role in upgrade from Version 3.1 to Release 4.0.1. Member MAXIMO Core Team and Emergency Response Team member.

Maintained cGMP standards for janitorial and pest control inspections within three site campuses. Maintained facility landscaping, interior plants, satellite copy centers, mail center stations and related equipment, office supplies, recycling, shredding, conference rooms, and audio-visual equipment. Supervised 10 General Office Clerks. Trained crew in customer service techniques. Planned and tracked $6+ million annual budget. Interacted with vendors to ensure quality services. Specified and purchased mailing systems, copiers, audio-visual equipment and office supplies. Developed and negotiated proposals with outside landscaping and copier service vendors. Member of Move Transition Team that moved 1,600 employees from Palo Alto facilities to HQ in Mountain View. Worked with vendors to ensure service continuity during move without staff increase.

Created work orders, PMs, job plans and related files. Generated MAXIMO reports using SQL. Controlled and purchased parts inventory and supplies for Department using MAXIMO CMMS information. Created and maintained filing system for the campus, ensuring accessibility to FDA required documentation. Electronically archived Maximo daily and performed database maintenance as necessary. Created user profiles, installed CMMS files for new users, and trained users in system usage. Direct support of the Palo Alto Plant Engineering Supervisor and eight Maintenance Mechanics. Scheduled meetings and vendor service calls. Made department travel arrangements. Responded to telephone calls, including Emergency Response line, and dispatched mechanics.