Preventative Maintenance Continuous Improvement

Sean Matthews

Ayer, MA ***** 978-***-**** ********@*****.***

MAINTENANCE & ENGINEERING BIOPHARMACEUTICAL MECHANIC

Experienced engineering and manufacturing mechanic in the Biotech/Pharmaceutical industry. Efficiently managing projects with attention to detail, safety, and sense of urgency. Strive to collaborate on teams with effective communication, motivation, and drive to meet results and goals.

AREAS OF EXPERTISE

Vendor & Stakeholder Management Mechanical & Engineering OSHA GMP SOPs Communication FDA Compliance Continuous Improvement Troubleshooting & Resolution Management Preventative Maintenance

TECHNICAL KNOWLEDGE

Ariba SAP DELTA V Syncade LIMS Trackwise MSG/PRO Rosemount Workday

Microsoft Office LMS Systems PLC/HMI Interface Electrical & Mechanical Technology CMMS Systems Skilled Trade Tools

PROFESSIONAL EXPERIENCE

Lantheus Billerica, MA January 2023 – Present

Engineering & Manufacturing Technician

Provide meticulous, detail & safety-oriented support via communication skills with a team player attitude. Honesty & integrity in all work performance while remaining adaptable and self-motivated to meet department goals.

Support Commissioning equipment & oversee vendor/engineers for site requirements. Validation investigation for site deviations and preventative maintenance.

Cross functional support of manufacturing processes & operation coverage with utilities maintenance & repair to include cooling water system, and compressed air.

Proactively monitors system performance through application of process performance tools (PC, SIC, Metrics etc.), Identifies opportunities for improvement in reliability, repeatability, and efficiency. Communicates and applies improvements with full compliance to OSHA, cGMP, FDA, and NRC regulations utilizing SOPs for documenting changes and testing.

Troubleshoots, repair & maintenance services for production related systems and components includes linear motion, high vacuum, process water cooling, hydraulics, pneumatics, remote handling, and PLC/HMI interfaces.

Cross functional support to manufacturing processes, JIT environment include the performance of operation coverage. Fabricates and/or modifies mechanical/electrical components, as required, in support of maintenance activities.

Repligen Marlboro, MA January 2022 - August 2022

Senior Maintenance Technician

Managed vendor & engineering site requirements, project support, consultation with engineering staff and advised supervisory staff.

Commissioning of all equipment & oversee vendor/engineer for site requirements. Provide validation investigation for site deviations and preventative maintenance to determine risk assessments.

Consult with engineering staff on project and aid as required & advise Supervisor/Manager of problems.

Oversee maintenance team and take lead on multiple projects. Scheduled repair, and maintenance to adhere to manufacturing schedule during projects, new roll outs, or procedures.

Start-up of equipment, preventive maintenance, equipment/building repairs & change overs.

Support senior management on engineering maintenance within budgetary constraints.

Mechanic skills include but are not limited to HVAC system repair, electrical, plumbing, steam generator, experience with hydraulics, mechanical & electronic equipment. Trouble shoot & repair production equipment.

Perform highly diversified duties to install & maintain production machines and the plant facility equipment.

Provide emergency/unscheduled repairs of production equipment during operation.

Sean Matthews ********@*****.*** page two

Takeda, Lexington, MA November 2020 – November 2021

Senior Maintenance Mechanic Lab Operations

Preventative Maintenance: Utilize CMMS to manage completion of preventative & corrective maintenance, continuous improvement via evaluation of equipment performance and system design.

Troubleshoot and repair systems and equipment. Provided lab support for movement of materials, parts management, mounting equipment, and general technical assistance.

Vendor management, contract review and requests. Facility supports & rounds of biotech campus.

Pfizer, Andover, MA

Senior Mechanic March 2019 – October 2020

Responsible for operation of process support systems and equipment, provided technical and professional services for the facilities group.

Ensure safe performance of all repairs, maintenance, and project activities. Operate and perform daily checks of utility’s gray spaces, calibration, utilities & process, aseptic, bioreactors, tangential flow, centrifuge, chromatography columns/skids, glass washers, ultrafiltration, autoclave & pure water systems.

Troubleshoot, work cross function within the maintenance group, and be prepared to apply technical leadership and professional support for facility and maintenance operations.

Support continuous improvement and development of maintenance practices, escort contractors and vendors for the performance of preventative maintenance and repairs on process support systems.

Maintain records to comply with GMP detailed documentation of work performed in electronic & written form.

Insight Global. (client Pfizer Global Supply), Andover, MA July 2017 - January 2019

Validation Engineer III

Responsible team member prioritizing duties and cGMP for lifecycles and proper GDP compliance involved with engineering, Maintenance, and utilities to support facilities.

Validation Protocols for Suites. Installation, Operational, Performance Qualifications (IQ, OQ, PQ) in support of a 5-day cadence and concentrating on Cleaning in Place (CIP), Cleaning out of Place (COP) and Steam in Place (SIP)

Experience with QTS to implement change controls. Work daily in EAMS to generate/process work orders.

Sampling and all requirements/documentation necessary for validation protocols.

Documentation lifecycles from inception to archive with proper GDP for compliance.

Revalidation & all relevant GMP documents (P&iD).

Site knowledge of processes, shadowing, assisting, trouble shooting, equipment maintenance, in/out of suite, grey spaces; Preventative maintenance; valve elastomer change out, tank entry, vessel inspection, spray ball checks, experience with tank remediation duties & LOTO plans with guidance.

Maintenance for cross functional training situations between EMU and Mechanics.

ADDITIONAL RELEVANT EXPERIENCE

Spectra force (AbbVie contract Chemical Operator) September 2016 – February 2017

Sanofi Aventis Sr Manufacturing Technician May 2015 – October 2015

Kelly Services (Biogen Idec Contract Manufacturing Tech) June 2013 – January 2014

MIG Corporation (Union Bridge Carpenter) June 2005 – October 2012

Atlantic Restoration LLC (Allied Craftsman) June 2000 – March 2005

Union & Non Union Laborer/Subcontractor November 1994 - June 2000

EDUCATION

WPI Certificate Program for Fundamentals in Biomanufacturing - November 2012

OSHA 30+ Hours Renewed 2012

Second Class Fireman License September 2023 – January 2025

Red Cross CPR Certified

Undergrad Studies Wachusett Community College

HS Diploma ASRSD

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