Charles Mays Email and Phone Number
Fort Collins, CO, US
Charles Mays's Location
Fort Collins, Colorado, United States, United States
Charles Mays's Contact Details
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About Charles Mays
Over my career I have continued to build a diverse toolkit associated with continuous improvement, engineering, facilities, validation, maintenance, EHS, and operations management. I am a malleable associate that seeks to improve his management style through growing experience and with provided feedback. I thoroughly enjoy guiding and developing associates to be contributors and leaders. I thrive in team environments putting my lean practitioner and black belt certifications to great use. I am a self-motivated individual who believes in teamwork and is dedicated to the success of the company I work for.Key areas of expertise -Management in the following areas - manufacturing engineering, equipment engineering, packaging engineering, process engineering, controls engineering, facilities engineering, EHS, manufacturing/equipment maintenance, facilities maintenance, calibration/metrology, plant manufacturing/operations, machine shop/tooling shop, engineering/facility validation, facility compliance, site services, employee services, vendor management, building management, sustainability/corporate social responsibilities, etc.- Biotechnology manufacturing/laboratories- pharmaceutical manufacturing (aseptic/injectables/parenterals/dermatologicals/etc)- medical device manufacturing (collection/injectables/diagnostics/etc)- manufacturing equipment design- facility/lab/system/utility/site design- automation design- packaging component development- packaging equipment development- manufacturing/process optimization- operational excellence/continuous improvement of processes/systems- documentation/change management- financial analysis/budgeting/capital procurement- strategic planning- associate development- equipment commissioning/validation- facility commissioning/validation- change management/change control/requirement development- equipment and facilities maintenance and management- maintenance controls/systems- calibrations systems / management - validation & compliance in pharma and device industries- EHS systems/processes/improvements/accident prevention/behavior based/management
Charles Mays's Current Company Details
Ccm Consulting Llc
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Vice President, Engineering/Maintenance/Facilities/Validation/EHS at Tolmar
Fort Collins, CO, US
Charles Mays Work Experience Details
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Ccm Consulting LlcFort Collins, Co, Us
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Vice President, Engineering/Maintenance/Facilities/Validation/EhsTolmar Apr 2020 - PresentFort Collins, Co, Us
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Director Of Facilities OperationsIllumina Sep 2019 - Apr 2020San Diego, Ca, Us -
Associate Director Facilities OperationsIllumina Jan 2018 - Apr 2020San Diego, Ca, UsLead the facilities operations group for all San Diego sites which consists of site services, facility maintenance, facility engineering and validation, the compliance group, and event coordination. My teams’ scope of work encompasses 9 buildings and approx 1.3MM sq ft of office, manufacturing, lab, and warehouse space.
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Director Of Engineering And FacilitiesTolmar Jun 2015 - Dec 2017Fort Collins, Co, UsLead technical service groups (engineering,facilities,maintenance,controls, etc) for a pharma manufacturing and development company focusing on dermatological and aseptic manufacturing.Manage the technical capital budgets for 10 sites and the expense budgets for the site maintenance/engineering/facilities/etc departmentsDesigned and built fully functional 3200 sq ft QC/Chemistry lab. Also designed and built 1200 sq ft Micro lab.Implemented large capital procurement processes by generating templates for justification, requesting vendor proposals, and executing a design build.Oversaw aseptic manufacturing area design, construction, and validation support.Renovated manufacturing plant’s front office by generating an initial design and exulting the project while manufacturing continued.Consults and advise when new product/business opportunities arise. This included providing assessments of current facility capabilities,cost estimates for expansion,new building construction,or renovations.Represents the company in regulatory agency auditsTechnical resource/support provider for equipment (wet mill, autoclaves, isolators, lyophilizers, fillers, packaging equipment, serialization, etc) , systems (PLCs,BMS,CMMS,etc), and the facility (HVAC,Controls,water systems,BU power,finishes,pressurization,central gases,chilled water, electrical, etc).Aided in the design and managed the overall site plan which consists of drainage improvements, parking areas, construction, landscaping, relocation of utilities, water control through scuppers/gutters design,new roads,fencing,curbing,irrigation,etc.Renovating 80,000 sq ft office/warehouse building by generating the design and executing all aspects of construction including 160 person move to building. Implementing a new CMMS program for better tracking of activities, resources,job plans,spare parts,calibration,PMs.
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Senior Engineering Manager / Acting Director Of Engineering/Maint - Pharmaceutical ManufacturingCatalent Pharma Solutions Feb 2014 - May 2015Somerset, Nj, Us• Manage 10 engineers/technicians in the engineering and metrology departments plus additional contractors when required• Accountable for a 1.6MM department budget along with a 22MM site capital plan• Own an electronic data collection project reducing the errors within batch records related to quality sampling• Support and provide resources to a pilot project related to serialization of products• Driving 3 significant capital expansion/renovation projects in 2015:o $8.2MM for proper personnel flow and production suite GMP improvementso Redesigning chemical dispensary satisfying past GMP audit observations for Aseptic manufacturing o $22.1MM for the expansion of manufacturing/packaging area based on customer demand• Support continuous improvement initiatives including global TPM initiative• Support all New Product Development initiatives by developing packaging/manufacturing processes and equipment• Review/develop product artwork, label changes, new product designs, process/and system layouts• Provide 24/7 technical support for manufacturing issues• Write and deliver regular one-on-ones, mid-year reviews, and end of year reviews for direct reports• Coach, develop, and challenge associates by diversifying project assignments and department involvement• Coordinate engineering coverage for production by maximizing associate skillsets• Support the departments in the annual budgeting process as well as budget reforecasting -
Site Operations Manager - Pharmaceutical ManufacturingCatalent Pharma Solutions Feb 2013 - Feb 2014Somerset, Nj, Us• Managed 4 supervisors, 2 dispensary technicians, and indirectly 162 operators, formulators, sanitizers, and technicians• Implemented the right sizing of floor personnel project which reduced the headcount by 25% per shift• Managed the spending budget for the operations group• Scheduled head count allocation for $103MM revenue ($38MM EBITDA) manufacturing facility• Drove continuous improvement activities through manufacturing investigations, deviations, and correction processes• Supported internal auditing, ISO, customer auditing, FDA auditing and other regulatory agencies by providing tours, information, and preparatory work• Drove safety initiatives by participating on the site safety team, operations safety team, implementing a behavior safety audit process, completing safety incident investigations, and executing the resolution of safety concern observations• Worked closely with the supply chain and customer service department to meet customer’s expectations• Drove training of associates to increase efficiency and execute at a higher rate of right the first time• Supported all New Product Development initiatives from feasibility testing, clinical batches to validation and performance runs bringing exciting items to market in a timely manner• Review all New Product Development documentation (NPD), batch records, SOPs, etc., for the roll out of upcoming products
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Engineering Supervisor / Machine Shop Supervisor Medical Device ManufacturingBd Medical Jun 2008 - Feb 2013Franklin Lakes, New Jersey, Us• Supervised 19 hourly/salary associates in the SCM department and the plant machine shop• Wrote/delivered regular one-on-ones, mid-year reviews, and end of year reviews for direct reports• Coached/developed/challenged associates by diversifying project assignments and department involvement• Coordinated engineering coverage for production in the SCM departments by maximizing associate skillsets• Analyzed downtime/machinery faults/training gaps/process rejects measuring the financial impact thus linking it to material variance and labor cost• Supported departments annual budgeting process, BOM/Router adjustments, and budget reforecasting for coverage areas• Owned/coordinate the capital budget/spending in SCM and the Plant Machine Shop departments• Owned/drove the SCM Continuous Improvement initiatives (exceeded budget by 690k in FY11 & 520k in FY12)• Led the Nexiva Cost-to-Win initiative to reduce product cost by 33% by FY17 (currently exceeding expectations)• Represented manufacturing on the unit sustaining engineering group and the plant validation team• Managed SCM departments’ engineering priorities/projects• Supported/staffed the expansion of the Nexiva department (Automated line #2) • Managed the expansion/remodel of the machine shop and added resources/machinery to accommodate plant growth • Supplied machined components worldwide–Doubled swage pin output with equipment changes and shift adjustments• Implemented a quality tracking system, rush job monitoring system and improved cross training in the machine shop• Developed detailed reporting on the shop’s performance and status thus managing it as an operations department• Created lean culture in the plant machine shop (KAS, blitzes, work sessions, SWIs, 5s, PMs, etc.)• Rolled out leadership standard work instructions in the machine shop and SCM engineering• Blitz/Work Session facilitator for areas of focus. Taught Lean techniques to floor associates -
Staff Engineer - Medical Device ManufacturingBd Medical Nov 2007 - Jun 2008Franklin Lakes, New Jersey, UsStaff Engineer for Medical device Manufacturing • Supported NFA1vendor acceptance of equipment creating/ performing MSAs and validations on Z7 and Z8• Created support documentation for automated assembly process (PMs, SWIs, Calibration, LOTO, etc.)• Supported site testing, validation runs, documentation, and start-up of the NFA 1 production line• Trained technical/operating staff on Zone 7 and 8 equipment operation, maintenance, and resolution of system issues• Engineering Intern Supervisor – Managed the 4 interns, recruited replacements, and mentored the students• Drove CI initiatives and coordinated capital spending in the Zone 7 and 8 manufacturing areas• Coached, motivated, and guided operations associates keeping team engaged in tasks at hand • Utilized Lean Manufacturing and Six Sigma analysis tools to evaluate efficiency and productivity problems
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Senior Mechanical Engineer - Medical Device ManufacturingBd Medical Nov 2004 - Nov 2007Franklin Lakes, New Jersey, UsLead manufacturing / improvement engineer for five medical device automated assembly lines:• Aided in the plant cost saving annual initiatives such as budgeting, material variance reductions, labor reductions, etc.o Area engineer was responsible for proposing cost reduction initiatives to finance and plant leadership• Analyzed reoccurring downtime, machinery faults, personnel issues, and reject distribution assessing financial impact• Indirectly managed production line technical staff and supported day to day issues encountered by production associates• Maintained key production support elements (PM schedules, spare parts, shut down activities, etc.)• Created/implemented capital projects to resolve chronic problems associated with the production lines• Project manager for validation of automated assembly lines (PBBCS & PAH):o Organized/coordinated technical and operations resources to support validation and initiate ramp upo Designed, performed, and scheduled studies, DOEs, PCs, and MSAs in preparation of validationo Created support documentation for assembly process (PMs, SOPs, Calibration, LOTOs, etc.)• Utilized Lean Manufacturing and Six Sigma analysis tools to evaluate efficiency and productivity problems• Managed idle assets (three production assembly lines)o Scheduled monthly dry/product cycling and managed technical associates who maintained idle assets o Scheduled improvements on active production lines and tested potential line improvementsEquipment Acceptance/Installation/Validation/Start-up engineer for medical assembly line:• Zone 1 lead engineer supporting vendor acceptance of equipment performing DOEs, MSAs, and completing PFMA• Coordinated site testing, validation runs, and documentation(generation of SOPs, PMs, Calibration, LOTO, spare parts) • Supported start-up/Ramp-up of the production line• Trained technical/operating staff on equipment operation, maintenance, and resolution of system issues
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Staff Engineer / Project Manager - Consumer ElectronicsThomson Mutimedia 2000 - 2004Member of Technical Staff, Thomson Multimedia Inc., Lancaster, PA/Mexicali, MXAugust 2000 – July 2004Equipment Installation/Production Ramp-Up Manager of a relocated television assembly line:• Coordinated production schedules, manufacturing associates, and downtime during production line ramp-up• Multiple area installation, debug, and start-up project manager• Trained local operations/technical staff on equipment operation, maintenance, and troubleshooting• Coordinated test schedules, documented test procedures, completed installation and start-up documentation• Responsible for a diverse team of contractors, maintenance staff, manufacturing personnel, and outside vendors o Reviewed bid packages, prepared contracts, determined scope of work, evaluated proposals o Managed contracts during implementation to ensure compliance with proposed design, budget, and schedule o Reviewed change orders to the initial contracts and negotiated alterations to original agreementsEquipment Development Group Leader, assisted in the building of a new television picture tube manufacturing facility:• Worked with local operations support to derive a production schedule and ramp up plan• Managed multiple skilled engineers and technicians in a team environment plus scheduled the travel/work coverage• Maintained a 10 million dollar equipment and facilities project budget• Researched and selected vendors to build equipment• Created equipment specifications, test procedures, installation/acceptance documentation• Vendor tested/accepted equipment in the US and in Japan - Rotary indexing machinery, conveyer systems, In line automation devices, Furnaces (7m x 50m lehrs) and Standalone pressure weld equipment• Coordinated/managed on site installation, debug, testing, and production start-up (Relocating to Mexico)
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Mechanical Project EngineerIngersoll Rand / Torrington Bearings 1994 - 2000Project Engineer, Torrington Company (IR), Walhalla, SCMay 1994 to August 2000Equipment Design Engineer for a high volume bearing manufacturing facility:• Coached and mentored production workers increasing productivity and morale• Designed/constructed/implemented automated machinery that improved quality and productivity for existing/new products• Improved existing assembly machinery by implementing PLC’s, Vision Systems, and other modern technology• Designed and implemented automated assembly machinery for other Torrington Company facilities • Facilities Year 2000 Coordinator - Participated on a corporate team to insure compliance by testing, upgrading, and documenting all computer controlled devices at the manufacturing site• Packaging Department Engineer - Addressed material handling, process flow, quality, and safety issues• Supervised a complete renovation of the packaging department
Charles Mays Skills
Six Sigma
Lean Manufacturing
Engineering
Continuous Improvement
Quality System
Fda
Gmp
Manufacturing
Root Cause Analysis
Validation
Kaizen
5s
Cross Functional Team Leadership
Project Management
Medical Devices
Dmaic
Operations Management
Pharmaceutical Industry
Capa
Sop
Iso
Mrp
Design Of Experiments
Process Improvement
Change Control
Engineering Management
21 Cfr Part 11
Automation
U.s. Food And Drug Administration
Process Automation
Process Engineering
Fmea
Charles Mays Education Details
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Clemson UniversityMechanical Engineering -
Webster UniversityGeneral
Frequently Asked Questions about Charles Mays
What company does Charles Mays work for?
Charles Mays works for Ccm Consulting Llc
What is Charles Mays's role at the current company?
Charles Mays's current role is Vice President, Engineering/Maintenance/Facilities/Validation/EHS at Tolmar.
What is Charles Mays's email address?
Charles Mays's email address is da****@****hoo.com
What is Charles Mays's direct phone number?
Charles Mays's direct phone number is +197021*****
What schools did Charles Mays attend?
Charles Mays attended Clemson University, Webster University.
What skills is Charles Mays known for?
Charles Mays has skills like Six Sigma, Lean Manufacturing, Engineering, Continuous Improvement, Quality System, Fda, Gmp, Manufacturing, Root Cause Analysis, Validation, Kaizen, 5s.
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