Manager Maintenance

Charles A Hiller, Jr. CPMM, CSM

*******.******@***.***

SUMMARY OF QUALIFICATIONS

An adept troubleshooter with over 20 years as a successful leader, coach, and trainer of manufacturing teams in the Pharmaceutical Industry, experienced in successfully working with and leading cross-functional teams in a matrixed environment. A self-motivated, active problem solver experienced in the troubleshooting and repair of sophisticated processing and packaging equipment. An energetic, responsible, accountable, and results-oriented leader embraces challenges, builds cohesive teams, and successfully develops and implements lean process improvements. Also accomplished in and skilled at:

Preventive Maintenance

Predictive Maintenance

Certified Scrum Master

Practical Process Improvement

Project Management

Team Development

CPMM

Continuous Improvement

Metrology

PROFESSIONAL EXPERIENCE AND SELECTED ACCOMPLISHMENTS

Novartis Pharmaceutical, Morris Plains, NJ Reliability Engineer Dec 2018 to Sep 2020

Provide oversight for the asset care program related to equipment, systems, and utilities to ensure reliable operation, appropriate maintenance levels, and minimal downtime.

Lead the overall asset (equipment) care strategy for the site through the core equipment support functions (Equipment Experts, Facility Engineers, Automation Engineers).

Lead reliability life cycle management of equipment, including design (new equipment), operation, and maintenance. Including the identification and implementation of the site and global engineering best practices.

KPI Monthly Reports (both site and global)

Lead Project Manager in establishing the reliability program, overseeing scope, budget, and timeline.

Analyze equipment failures, trends, and implement appropriate CAPA actions to address them.

Implement optimal levels of maintenance to ensure equipment reliability.

Management of site CMMS system--Blue Mountain Regulatory Asset Management (BMRAM)

Maintain appropriate levels of spare and repair parts for all critical equipment utilizing BMRAM inventory.

Purchase and track all components required for planned maintenance and necessary spare parts for on-demand maintenance events.

Participate in maintenance planning activities to minimize disruption to production. Coordinate scheduled activities with E&F and Equipment Owners

Support capital investments concerning production facilities, master planning, and site infrastructure adhering to Novartis guidelines.

Supports/Prepares/Executes Engineering & Facility audits

Ensure the compliance of all (internal, regulatory, and statutory) QA, HSE, and NTO relevant guidelines, directives, and processes.

Support internal and external auditing activities.

Provide technical support to operations and support personnel

Maintain asceptic gowning qualifications for a Class A asceptic environment.

Novartis Pharmaceutical, Morris Plains, NJ Technical Equipment Expert Jul 2017 to Dec 2018

Responsible for overseeing and managing the planning, design, and implementations of capital equipment projects, requiring collaborations with external manufacturers and vendors and internal groups, including Finance, Manufacturing, Quality, Regulatory.

Establish User Requirement Specifications

Initiate and run projects leading to supply chain, process improvement, and manufacturing equipment expansion.

Support Sourcing and purchasing of equipment, vendor quotes, and purchase order placement and tracking.

Receipt and installation of equipment, including support for enrollment, equipment set-up, calibration, and activation.

Coordination of equipment interface to the building (BAS) and equipment monitoring systems (EMS) and required interface to all networks, Examples - LIMS, MES, or Data Historians.

Interact with end-users across departments during the equipment life cycle.

Ensures effective scheduling of all equipment/system PMs, calibrations, and repair activities consistent with approved SOPs

Support for commissioning/qualification activities, including document reviews and approvals, task executions, and coordination with end-users and vendors.

Establish measures to improve data integrity and data control of CGT equipment.

SME expert on equipment with responsibility for troubleshooting, service schedule, and repair oversight.

Maintain asceptic gowning qualifications for a Class A asceptic environment

Develop Analytical maintenance and calibration equipment procedures for CGT.

Coordination and support for change control activities related to equipment, including upgrades to existing hardware and software in compliance with GMP and HSE regulations

Support for training activities on CGT equipment.

Writing/working with end-users on Standard Operating Procedures for equipment regarding operations, calibration, and maintenance.

Work with Facilities personnel to ensure correct spare parts are identified and available.

Responsible for service agreements and contracts with equipment vendors.

Leads and ensures successful execution of maintenance actions during Plant Shutdowns and upgrade projects as assigned

Establish and monitor Key Performance Indicators (KPIs) for equipment.

Maintains close interface with all units (i.e., Quality Control, Quality, PU, MS&T, and TRD) to ensure equipment is kept in a state of cGMP for manufacturing operations

Sunny Delight, Dayton, NJ Technical Manager Dec 2016 to Jul 2017

Oversee all installation, repair, and upkeep operations of the company's facilities, processing, and packaging operations.

An active member of the site leadership team driving an OEE focused culture

Value Stream Manager for a high-speed bottling line championing and running lean continuous agile projects that reduced equipment downtime and increased OEE.

Develop maintenance procedures and ensure implementation

Carry out inspections of the facilities to identify and resolve issues

Plan and oversee all repair and installation activities

Allocate workload and supervise upkeep staff

Monitor equipment inventory and place orders when necessary

Monitor expenses and control the budget for maintenance

Manage relationships with contractors and service providers

Keep maintenance logs and report on daily activities

Ensure compliance with all health and safety policies

Johnson & Johnson, Lancaster, PA Maintenance Supervisor Sep 2013 to Nov 2016

Responsible for leading and directing Technical Associates in the daily support of the Manufacturing Operation. Ensure all direct reports are always 100% trained in required procedures for the execution of their role. Provide Leadership, teaching, coaching, and mentoring to Technical Associates and Operations Associates to better achieve tactical and strategic goals.

Ensured all technicians correctly entered and signed off on their work in a timely fashion n the SAP PM CMMS.

Led team to develop and implement skills in detecting and resolving equipment-related process constraints, reducing our time of implementation by 20%.

Participated as Subject Matter Expert in over ten successfully implemented equipment-related projects over two years, seeing increased operability of 35%.

Lead equipment-related continuous improvement projects while providing technical training to Technical Associates, resulting in the successful alignment of 5S, standard work, and Single Minute Exchange of Dies (SMED) events increasing Overall Equipment Effectiveness (OEE).

Led cross-functional team to redesign the technician training curriculum, resulting in a streamlined training matrix focusing on operational support and eliminating cross-training gaps. It has improved training metrics by 75% in six months.

Fisher Clinical Services, Allentown, PA Maintenance Engineering Supervisor Jun 2012 to Sep 2013

Responsible for analyzing, diagnosing, developing, and implementing packaging line operations process improvements. Responsible for developing all direct reports by implementing a robust training program.

As SME, Tier Board Coach, Trained Trainer, PPI Team Facilitator, and PPI Process Manager successfully implemented 5S, Standard Work, SMED, PPI, and TQM initiatives.

Participated in daily management review boards, and as needed, to lead the efforts to troubleshoot production/process issues and provide cost-effective, technically correct solutions to these issues.

Selected to represent maintenance engineering as an active member of the PPI Steering Committee

Actavis, Elizabeth, NJ Lead Instrument &Controls Technician Aug 2009 to Mar 2012

Responsible for leading teams consisting of junior calibration engineers and third-party service contractors to perform scheduled and unscheduled facility/process equipment calibrations.

Responsible and accountable for understanding the process and business impact of instrumentation failures and analyzing, diagnosing, and quickly implementing solutions to minimize those failures.

Responsible for providing accurate and compelling business cases for instrumentation improvements to existing equipment installations.

Accountable for all documentation regarding Instrument Out of Tolerance and deviation issues and for specifying new and replacement instrumentation needed to resolve these issues.

Responsible author for all I&C SOPs.

Selected as Blue Mountain "Regulatory Asset Manager" and "CALMAN" administrator.

Project manager for various equipment expansion and upgrade initiatives. Provided input and guidance for instrument specification, system design, and IQ, OQ, PQ activities.

Genzyme Biosurgery, Ridgefield, NJ Lead Calibration Technician Aug 2005 to Aug 2009

Responsible for the calibration of all instrumentation and performing additional, more complex measurement uncertainty analysis as needed.

Determine methods and procedures on new instrumentation and provided recommendations for implementation.

Authoring of SOP's

Reviewed documentation submitted by calibration technicians to ensure that accurate, concise documentation is provided and meets all of the cGMP and internal SOP requirements.

Assisted Departmental Manager with all training.

Maintain asceptic gowning qualifications for a Class A asceptic environment

Directly guided other technicians to ensure compliance with cGMP's and (SOP's).

As an active member of the Safety Committee, successfully led and implemented OHSAS 18001 standards within the facility.

Led all NCR (nonconformance reports) investigations and as well as FMEA analysis

Successfully implement Six Sigma strategies as part of the company's Total Quality initiatives.

Wyeth Pharmaceuticals, Pearl River, NY Instrumentation Mechanic Oct 2003 to Aug 2005

Primarily responsible for the calibration and preventive maintenance of process equipment and maintaining accurate records of work performed.

Regularly required to perform all troubleshooting and repairs of equipment, including, but not limited to, Siemens S7 and Allen Bradley PLC's.

Ensured all Standard Operating Procedures and cGMP standards were met or exceeded to ensure equipment compliance.

Organon, West Orange, NJ Production Equipment Technician Nov 2002 to Oct 2003

Responsible for performing maintenance and installation of equipment in a sterile production environment.

SME on Siemens S7, Allen Bradley, GE, and Direct Logic PLC's. Troubleshooting input and output signals.

I was selected to help write Standard Operating Procedures for equipment based on my experience and industry knowledge.

Maintain asceptic gowning qualifications for a Class A asceptic environment

Worked on multiple projects to upgrade equipment, improving the manufacturing process, and increasing reliability while reducing changeover times and unplanned downtime.

Romaco Inc., Pompton Plains, NJ Field Commissioning Engineer Feb 2001 to Aug 2002

Responsible for installing, qualifying, repairing, and maintaining processing equipment used in the pharmaceutical industry. Performed factory acceptance tests and commissioning on equipment throughout North America and Europe. Managed third-party contractors to ensure proper installation of equipment.

Created and scheduled preventive maintenance schedules and programs, generating additional revenue while saving customers on equipment repairs and service.

Assisted Project Manager to ensure projects were completed on time and within budget.

Worked closely with customers to assist with the installation, operation, and process qualification of their equipment, ensuring it met all regulatory standards and requirements and the customer's expectations.

United States Navy, Norfolk, VA Petty Officer Third Class Interior Communication Electrician 1986 to 1989

Interior Communications Electricians (IC) operate, coordinate, and perform organizational and intermediate maintenance on alarm, warning, and indicating systems, interior communication systems, ship's speed and steering control systems, power generation and distribution systems, data conversion and distribution systems, aviation monitoring and landing aids, information and training systems, gyroscopic navigation systems, and environmental systems; interpret and analyze ship's blueprints and system interface diagrams; inspect, test, analyze, and make detailed casualty analysis; and direct repair of electrical, electronic, fiber optic, hydraulic, mechanical, and synchro and servo systems.

EDUCATION

Colorado State University Online, Greenwood Village, CO

Bachelor of Science Project Management (April 2020 graduation, 3.97 GPA)

Applied Strategic Project Management for the 21st Century (certificate)

Foundations of Project Management (certificate)

Excelsior College, Albany, NY

Associates Applied Science Technical Studies, Electronic/Instrumentation Technologies (4.0 GPA)

County College of Morris, Randolph, NJ

Assembly & Testing (certificate) (4.0 GPA)

Basic Telecommunications Fundamentals (certificate) (4.0 GPA)

The United States Navy Education Center

Basic Electronics & Electricity Class P School

Interior Communication Electrician, Class A School

Interior Communication Electrician CCTV, Class C School

Professional Development

Certified Scrum Master (certificate, Scrum Alliance)

OSHA 10-hour

Certified Professional Maintenance Manager (certificate, AFE)

Certified trainer

How Adults Learn

Instructional Coaching

Instructor-Led Training

Facilitator, Practical Process Improvement

Process Manager, Practical Process Improvement

Project Management (certificate, AMA)

Microsoft Project (certificate, AMA)

Process Mapping (certificate)

Creative Leadership (certificate)

Statistical Process Control (certificate)

Scientific & Technical Writing (certificate)

Lean Manufacturing – Continuous Improvement Methods (certificate)

Six Sigma Implementing Methods (certificate)

Automation

Introduction to Process Controls (certificate, ISA)

Control Logix Programming (certificate, Rockwell Automation)

SLC 500 Programming (certificate, Rockwell Automation)

Autocad 2007 (certificate, Autodesk)

Autocad Electric 2007 (certificate, Autodesk)

PLC Programming (certificate, Bergen County Tech)

Siemens Step7 Maintenance (certificate, Siemens)

Toshiba CS6600 (certificate, Mosler Education Center)

COMPUTER SKILLS

Microsoft Office

MP2

Calman

Regulatory Asset Manager

Maximo

PLC

AutoCAD

SAP PM

EDM

ETQ

Compliance Wire

Trackwise

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