James a.hinkle resume quality manufacturing 1976 - 2016
Resume_ScottAReese
1. Scott A. Reese
21 Rice Corner Rd. scott.reese@genzyme.com (508)962- 8960 (C)
Brookfield, Ma. 01506 (508)271- 3522 (W)
PROFESSIONAL SUMMARY
• A highly organized and motivated facilities professional and project team leader with 20+ years’
experience in project, plant and critical utilities management in a highly regulated industry.
• Strong record of contributing to quality outcomes, productivity improvements, performance
enhancement and ROI/cost reduction.
• Develop and implement a robust training program including Training Needs assessments,
Skills Matrix and Skills assessments, compliant with Genzyme Training Standards.
• Support regulatory audits for multiple agencies (FDA, EMA, PMDA, etc.) for both Medical
Device and Biologic’s business units. Mitigate audit findings (CAPA’s) to resolve facility
compliance issues.
• Multi-site Incident Commander.
• Review, approval and executing validation and commissioning protocols. Develop & implement
facilities, maintenance & engineering programs and operational procedures.
• Managing equipment design, installation and maintenance in a validated environment under cGMP
guidelines.
• Utilized RCM, FMEA, historical data, RCFA to develop best in class maintenance practices, spare
parts and continuous improvement strategies to reduce costs and improve asset reliability.
• CPMM and SMRP certifications support development of a strong reliability, safety and
environmentally focused maintenance programs
• Perform gap assessments for 65 company, all local and federal standards and regulations. Develop
and implement remediation plans to ensure process and procedure compliance to the standards.
EXPERIENCE
Genzyme, (a Sanofi Company) Framingham, Ma. 2010- present
Manufacturing and research based pharmaceutical company with global operations.
ASSOCIATE DIRECTOR FACILITIES SHARED SERVICES, (2010-PRESENT)
♦ Responsible for Project Managers, Operations Managers, Systems & Automation Engineers,
Reliability Engineers, Quality Engineers, Training Manager and specialists, Central Inventory
and GMP operations at the Framingham and Northboro locations.
♦ Developed and implemented department SOPs and Engineering Practices to ensure alignment
with Genzyme’s Corporate Quality Operations Standards.
♦ Develop and implement a Capital Projects Life Cycle Management program with a “Phase
Gate” model from Basis of Design through Decommissioning.
♦ Develop and implement a Engineering Change Management Program to control business and
safety critical assets.
♦ Site Risk Champion responsible for developing and maintaining a risk profile report and
mitigating identified business and compliance risks.
♦ Site Quality Champion, responsible for assessing departmental processes and procedures for
gaps and developing/implementing remediation plans for 65 Genzyme standards. Responsible
for supporting multiple business units and quality management review boards.
♦ Provide facilities project support, start up and management oversight of the 250,000 sq. ft
Global Distribution Center in Northborough.
♦ Provide support for all internal and external regulatory audits, responses and CAPA
completion.
♦ Provide Clean/Pure systems maintenance, diagnostics and repair guidance to Genzyme global
community.
2. Scott A. Reese
♦ Support OLT/SLT meetings for multiple business units.
♦ Responsible for Building Automation Systems and Environmental Monitoring group that
provides CFR 21, Part 11, project and daily operations support.
♦ Responsible for Shared Services Training and Compliance department.
♦ Successfully managed 17 direct, 60 indirect reports and contractors.
♦ Establish departmental and individual goals and objectives in alignment with site goals and
priorities. Identify performance improvement targets and metrics. Ensure capabilities and
capacities are in place to deliver on all manufacturing commitments and performance targets.
♦ Identify and communicate risks in area of responsibility and across the site, create strategies
and plans to manage risk to manufacturing operations.
♦ Oversees budgeting processes ensuring facility and maintenance remain current with the
needs of the operation.
FACILITIES OPERATIONS MANAGER, CLEAN UTILITIES SME (2008- 2010)
♦ Facilities operations manager overseeing three manager level direct reports, four supervisors,
one maintenance scheduler and twenty one technicians. Responsible for Therapeutics,
Biosurgery, Clinical Manufacturing and Diagnostics support at the Framingham and Northboro
locations.
♦ Piloted and implemented first industry rouge monitoring program for WFI and Clean Steam
systems. Implemented minerals and heavy metals monitoring program for RO and pure water
generation, storage and distribution systems.
♦ Forecast capital and expense budgets 95M.
♦ Support Capital Projects and Engineering departments on design and development of all new
facilities and upgrades.
♦ Provided Clean/Pure system issue resolution for Genzyme sites world wide.
♦ Provided RO/DI, Clean Steam and WFI system maintenance in San Diego Ca.
♦ Implemented Reliability Centered Maintenance approach and PDM principals to achieve
increased equipment uptime.
FACILITIES MANAGER , CLEAN UTILITIES SME (2006- 2008)
Responsible for two managers, four supervisors, eighteen technicians and necessary contractors
to maintain seven manufacturing plants throughout the Framingham campus while providing R&D
pure systems support and other departmental goals as required.
♦ Facilities lead on capital project for relocating Genzyme Diagnostics Group from Kendal Sq. to
Framingham to include design/start- up/commissioning and validation efforts.
♦ Support of all regulatory audits including internal CQC, IMB, MHRA and FDA authorities.
♦ Provided national support for Genzyme New York and San Diego sites.
♦ Provided world wide support for Kent, England, Waterford, Ireland and Lyon, France Genzyme
sites resolving pure system issues through engineering and procedural
modifications/recommendations. Provided FDA warning letter response for Lyon, France to
include High Purity Water system modifications, QA, QC and Metrology departmental
procedure changes.
♦ Facilities lead on $140M Cell Culture Plant project.
♦ Assisted in the implementation of Reliability Based Maintenance and Engineering.
♦ Assist in developing and maintaining capital budgets for all manufacturing cost centers in
Framingham.
♦ Ensured department compliance regarding QA, CAPA’s, QC, Environmental Monitoring and
Metrology, scheduling and MDR impact assessments.
♦ Participant in the Genzyme Maintenance Conference which is a program that allows world
wide facilities groups to establish and implement maintenance best practices.
♦ Manage Manufacturing area’s cleaning contractor and all associated SOP’s.
3. Scott A. Reese
♦ Implemented external maintenance contracts for Emergency Generators, UPS systems and Air
compressors.
♦ Provided facilities/engineering support for +40 internal capital projects including all document
and system change control compliance.
♦ Drive employee development through internal and external trainings and guidance.
Genzyme, Corp. Framingham, Ma.
FACILITIES SUPERVISOR, CLEAN UTILITIES SME (2002- 2006)
Responsible for the management or support of all facility related services including, but not
limited to, facility maintenance, engineering, QA, QC, metrology, environmental, security, health
and safety departments. Supervised five direct reports and responsible for all contract personnel.
♦ Reduced site operating expenses by implementing a RO water system pre-filter study
resulting in an annual $70K cost savings.
♦ Developed direct reports through annual reviews and trainings to allow for internal pure
systems support while reducing reliance on out side resources.
♦ Provided all documentation review to ensure cGMP compliance.
♦ Coordinated/scheduled day to day work responsibilities for all direct reports.
♦ Fielded all emergency/high priority work and provided the required resources to maintain
customer satisfaction and systems up time.
♦ Provided on-call assistance for all on-call technicians at the Framingham campus.
♦ Supported all regulatory audits for the Biosurgery and TMD business units.
Genzyme, Corp. Framingham, Ma.
FACILITIES LEAD TECHNICIAN , CLEAN UTILITIES SME (2000- 2002)
Maintained all Framingham campus buildings, systems and utilities while providing support and
training for lower level technicians.
♦ Responsible for operation and maintenance of all aspects of HVAC, City, DI and WFI water systems, Pure
and Plant Steam systems, Chilled Water, Compressed Air, Polishing and Waste Water systems.
♦ Provided engineering, QA, QC, metrology, environmental, security, health and safety department support.
♦ Provided 24 hour on-call support.
♦ Participated in developing, updating and maintaining all Facilities related SOP’s.
♦ Developed RO/DI water systems maintenance team and membrane cleaning tracking documentation
system.
♦ Advised management on systems requiring upgrades to support capital budget efforts.
Genzyme, Corp. Framingham, Ma.
FACILITIES TECHNICIAN (1996- 2000)
Took facilities lead on the GTR project in Framingham, providing start up, commissioning
validation and system ownership/maintenance after turn over. Helped to maintained all other
Framingham campus buildings, systems and clean utilities while providing support and training
for pier technicians.
♦ Responsible for operation and maintenance of all aspects of HVAC, City, DI and WFI water systems, Pure
and Plant Steam systems, Chilled Water, Compressed Air, Polishing and Waste Water systems.
♦ Provided engineering, QA, QC, metrology, environmental, security, health and safety department support.
♦ Provided 24 hour on-call support.
♦ Participated in developing, updating and maintaining all Facilities related SOP’s.
Creative BioMolecules, Hopkinton, Ma.
GMP FACILITIES TECHNICIAN (1993- 1996)
♦ Provided internal construction project design and labor. Designed and built labs, dark rooms and other
remodeling projects throughout the manufacturing and research facilities.
4. Scott A. Reese
♦ Responsible for operation and maintenance of all aspects of HVAC, City, DI and WFI water systems, Pure
and Plant Steam systems, Chilled Water, Compressed Air, Polishing and Waste Water systems.
♦ Performed metrology calibrations on various manufacturing and facilities equipment and instruments.
♦ Provided engineering, QA, QC, metrology, environmental, security, health and safety department support.
♦ Provided 24 hour on-call support.
♦ Participated in developing, updating and maintaining all Facilities related SOP’s.
Archetectural Fire Places, Franklin, Ma.
PRINCIPAL INSTALLER (1991- 1993)
♦ Provided internal construction project estimates, design and labor. Led a team of three installers by
coordinating and directing daily instillation efforts for zero clearance heating systems in both new and
occupied construction sites.
♦ Maintained all vehicle and equipment records.
♦ Ensured all contractors paid in a timely manor.
Wayne Toll Remodeling and Restoration, Boston, Ma.
PROJECT SUPERVISOR (1989- 1991)
♦ Provided estimates for wood refinishing and painting jobs in the Boston area.
♦ Acted as a working supervisor to complete upscale remodels and new construction projects.
All Seasons Remodeling, Excelsior Springs, Mo.
O WNER (1987- 1989)
♦ Provided estimates for home and basement remodeling, plumbing, electrical, drywall, decks, roofs, wood
refinishing and painting in the Kansas City area.
♦ Acted as a working supervisor to complete upscale remodels and new construction projects while directing a
crew of four laborers and various subcontractors.
Highland Glen Elderly Housing, Westwood, Ma.
Technician (1985- 1987)
♦ Maintained all apartments and common areas of a multi building senior living facility. Performed all
Preventive & Corrective Maintenance, Painting Remodeling, Landscaping and Snow Removal.
EDUCATION/TRAINING
High Purity Syst e m s Training
Pharmaceutical Water Treatment, David H. Paul, Inc.
Concentrated Reverse Osmosis Water Treatment, David H. Paul, Inc.
Advances in Biofouling Control, David H. Paul, Inc.
UtraPure Water, Millennium FRI
WFI Water, Millennium FRI
Intermediate Operator Training PW & WFI, Millennium FRI
Maintenance of Mueller Pure Steam Generators, Mueller
Building Manag e m e n t Syst e m Training
Level One Signal Operator’s, ENE, Inc.
Work Place Tech Programming Course, ENE, Inc.
Level Two, Network 8000 ASD Bus Programming, ENE, Inc.
Level 3: Facility Management, ENE, Inc.
Additional Trainings
5. Scott A. Reese
Introduction to Electronics, Assabet Valley Trade School.
Boiler Operations, NTT, Inc.
Refrigeration/Air Conditioning, NTT, Inc.
Instrumentation and Control Programming, NTT, Inc.
Maintenance Welding Procedures, NTT, Inc.
Second Class Fireman Course, NRG ES Inc.
Industrial Electrical Skills for Non-Electricians, ATMS
Introduction to Planning and Scheduling, MRG
Introduction to Reliability Based Maintenance Strategies, MRG
Other position relate d training information available on reque s t
PROFESSIONAL LICENCES & AFFILIATIONS
♦ Massachusetts Waste Water Treatment License, Grade 1-I FULL
♦ SMRP/CMRP Certification 2011 (Society for Maintenance and Reliability Professionals)
♦ CMMP Certification 2011 ( Certified Maintenance Management Professional)
♦ Massachusetts Boiler, Special License to Operate,
♦ HVAC EPA License , ECHO Institute
♦ Massachusetts Construction Supervisor’s License
♦ AFE, ISPE
SKILLS
Knowledge of computer programs including Microsoft Office, Excel, Microsoft Projects, AutoCAD,
Smart Solve, TrackWise, DataStream (Infor), NEXTS, SAP, Gauge Insite, GXP, Invensys (ENE) &
Honeywell BMS/EMS open platform systems. FMEA and RCM Risk Analysis tools. Subject Matter Expert
for Reverse Osmosis, Purified Water, Clean Steam and Water for Injection Systems and HVAC
systems.
6. Scott A. Reese
Introduction to Electronics, Assabet Valley Trade School.
Boiler Operations, NTT, Inc.
Refrigeration/Air Conditioning, NTT, Inc.
Instrumentation and Control Programming, NTT, Inc.
Maintenance Welding Procedures, NTT, Inc.
Second Class Fireman Course, NRG ES Inc.
Industrial Electrical Skills for Non-Electricians, ATMS
Introduction to Planning and Scheduling, MRG
Introduction to Reliability Based Maintenance Strategies, MRG
Other position relate d training information available on reque s t
PROFESSIONAL LICENCES & AFFILIATIONS
♦ Massachusetts Waste Water Treatment License, Grade 1-I FULL
♦ SMRP/CMRP Certification 2011 (Society for Maintenance and Reliability Professionals)
♦ CMMP Certification 2011 ( Certified Maintenance Management Professional)
♦ Massachusetts Boiler, Special License to Operate,
♦ HVAC EPA License , ECHO Institute
♦ Massachusetts Construction Supervisor’s License
♦ AFE, ISPE
SKILLS
Knowledge of computer programs including Microsoft Office, Excel, Microsoft Projects, AutoCAD,
Smart Solve, TrackWise, DataStream (Infor), NEXTS, SAP, Gauge Insite, GXP, Invensys (ENE) &
Honeywell BMS/EMS open platform systems. FMEA and RCM Risk Analysis tools. Subject Matter Expert
for Reverse Osmosis, Purified Water, Clean Steam and Water for Injection Systems and HVAC
systems.