Pharma & Biotech SIG

Pharmaceutical & Biotech SIG

SIG Leadership:

Chair
Robert Bishop
 
Vice-Chair

 

Members at Large
Rob Christman
robert.christman@genzyme.com
 
Robbi Talley
 
Past Chairs
Marie Getsug
marie.getsug@jacobs.com
 

ASK THE SIG

Welcome to the Pharmaceutical and Biotech Shared Interest Group!

Maintenance, reliability and physical asset management often take up a large portion of a pharmaceutical or biotech company’s overall budget. Because of this, professionals in the industry face increased pressure to ensure laboratories and machinery run properly and perform efficiently. This pressure is amplified by the need for the products produced by these companies for patients that my face life-threatening conditions.

The SMRP Pharmaceutical and Biotech SIG helps facilitate the education and achievement of world-class reliability, maintenance and physical asset management practices such as those defined in the International Society for Pharmaceutical Engineering (ISPE) ISPE Maintenance Guidebook.

Benefits of Joining the SIG

  • In-person meetings, monthly conference calls and online discussions diving into key industry issues and trends.

  • Benchmarking capabilities that help improve overall uptime, asset reliability, utilization and performance at respective companies.

  • Access to a vast network of industry professionals in similar positions and industries.

For more information on the SIG, click here.


Participate in the Pharma & Biotech SIG

To receive communication from this SIG and participate in meetings, complete the online interest form.

Interested in becoming an SMRP member? Learn more about our membership options here.


SIG Upcoming Events/Webinars

The Pharma & Biotech SIG meets the first Wednesday of every month at 12:00 pm Eastern.

Upcoming Webinar Presentations
Note: Registration for most webinars will open in February.
 
February 1, 2017: Reliability Best Practices Make Sense. So, Why Can't You Implement it? - REGISTER HERE
When faced with a major change initiative within the company such as Lean, Six Sigma, or Reliability Excellence leaders establish a project management group to handle the project. Tasks are subsequently divided and delegated. Resources are allocated and a utilization plan created. So what is the problem? Why can’t we implement these improvement projects? 
 
Lean, Six Sigma, and Reliability Excellence are all worthy improvement projects and many people would consider them the “right answer” to your current problems. However, as you may have already found out yourself. The right answer is not enough! Why do all your crafts resist the implementation of planning and scheduling? Why does your operations management counterpart resist all your efforts to improve his OEE numbers? Or even worse, your boss wants you to implement this but why won’t he give you the support you need?
 
This webinar explores the reasons why our efforts are often met with heavy resistance and what we can do about it.
 
About the Presenter
Dave Berube has over 20 years of experience in leadership, management, and transformational change within organizations. A Principal Consultant for Life Cycle Engineering (LCE), his expertise is focused on helping both public and private enterprises improve performance by implementing Reliability Excellence (Rx), Lean best practices and change management. Dave has assisted both national and international companies implement major change initiatives and provide coaching to senior leaders and managers on their roles in leading and transitioning through change. His track record of repeated results and expert coaching has resulted in the increased change competency of the people and organizations he consults. Dave is a U.S. Navy veteran, has an MBA from Webster University and is a certified Prosci Change Management professional.
 
March 1, 2017: Vibration's Role in IIOT
Vibration data is collected by many organizations, but it isn't always integrated into the systems and communications we use to make day to day decisions.  We will discuss what vibration data is, how it is useful and why it needs to be integrated into our decision process. 
 
About the Presenter
Joseph Lauria CRL is the VP of Sales for SEC of America.  He has a BS Mechanical Engineering from Rochester Institute of Technology and an MBA from Union College. He has implemented wireless condition monitoring systems at various facilities and has a passion for reliability, outdoor activities, hiking and family.
 
April 5, 2017: Paradigm Shift Strategy for Asset Management Analytics
The session will help explore a different new perspective of Strategy for Asset Management Analytics. The speaker will explain the various components and processes enabling you to think about a winning strategy for doing effective analysis for physical assets spread across the entire organization. 
You will learn:
  • Core Competencies for Performance Improvement
  • KPI Hierarchy Strategy
  • Building KPI Hierarchy 
  • Data Analysis Based Asset Performance Maturity Model
  • Building the strategy maps 
  • Dashboards, Metrics
About the Presenter

Johnny Bofilios has spent more than 19 + years in the software and consulting services industry, helping clients achieve sustainable improvements in asset performance. Has got industry experience in aligning customers’ valid business requirements with demonstrable technological application value within the transportation, oil & gas, energy, insurance, healthcare, financial services, pharmaceuticals, medical equipment, property management/real estate, construction and local governments/public sector market sectors.Demonstrated leadership in collaborating with the customer, products on tactical sustainable business development objectives focused on greater customer compliance and asset sustainability for increased energy efficiencies, greater market share, profitability, and customer ROI. He received his degree in Electrical Engineering from Clemson University.

May 3, 2017: New Standards for Food Grade Lubricants
Recent expectations have changed with regard to food grade lubricants.  These new standards will be reviewed to give you an idea of how they may affect your applications. 
 
About the Presenter

Wesley Cash is the Director of Technical Services at Noria.  He has been with Noria for over 5 years and brings with him a wealth of knowledge and experience around lubrication practices.  He has traveled to many companies to assess and train on lubrication practices and is involved with the greater reliability community.  He also has an engineering degree from Oklahoma State University.

June 14, 2017: Managing Risk in Spares

The Bio Pharma industry is inherently risk adverse when it comes to managing spare parts.  As a result, there is a strong resistance to change part manufacturer and or supplier. This resistance creates a supply risk that is often overlooked.  In the Bio Pharma sector there is a significantly high percentage of items for whom there is a single approved supplier (sole source parts).   The webinar will discuss how to transition parts from sole to multiple source position to eliminate supply risk while mitigating performance risk.

About the Presenter
Donald P. Shoemaker, P.E., Vice President, Asset Services 
As Vice President, Asset Services, Don practices a bilateral and strategic approach to asset management services aimed at accomplishing client objectives. This approach includes a comprehensive understanding of the plant environment and perspective on the requirements of individual sites as they relate to the supply chain. Previously, Don worked as an engineer for 18 years in design, installation and maintenance of chemical feed systems. Don has a BS in Mechanical Engineering from Cornell University, is a registered Professional Engineer and has taken continuing education classes in contract law through the Engineer Society of Philadelphia. 
 
July 5, 2017: Breathing New Life Into an Existing PdM Program
  • Training in house personnel on the capabilities of various PdM technologies.
  • Mentoring Reliability Engineers on program management.
  • Shifting the ratio of in-sourcing/out-sourcing inspections to improve overall effectiveness.  
  • Marketing successes to management to ensure program longevity.   
About the Presenter
Sean O’Connor CMRP, CRL
  • 12 years of maintenance and reliability experience.
  • Began career in maintenance while enlisted in the United States Marine Corps as an avionics technician. 
  • Served honorably for 5 years, completing two deployments.  One to Iraq in support of Operation Iraqi Freedom, the other to Okinawa, Japan. 
  • Transitioned into the civilian world as a PdM Technician with Mistras Group Inc, an inspection services company, in Princeton, New Jersey.
  • Spent 7 years conducting PdM inspections all over North America across many industries; oil/gas, pharma, food & beverage, power generation
  • Currently working for JLL as the PdM SME on our Bristol-Myers Squibb account.
  • Level I Acoustic Emission
  • Level II Vibration Analysis
  • Level III Infrared Thermography  
August 2, 2017: Work Execution Auditing

Auditing of work execution can identify opportunities for improvements as well as reinforce current practices.   Learn some of the steps needed to implement your own work execution audit program.  You will also get an excel spreadsheet to jump start your process.  

About the Presenter

Derek Burley CRL, CMRP, MIAM
Derek spent twenty years working in British Rail signaling as a control and systems engineer. It was while working in this capacity that he became heavily involved with RCM – an involvement that has continued for more than 25 years. In 1997 and moved to the US working as an RCM consultant across a wide range of industries. 

In 2003 he joined Cargill and established training programs, facilitation certification and standards development. In 2008 he moved Rio Tinto as Principal Advisor - Tactics Development, based in Salt Lake City. 

Derek is a founding member of IAM. He has presented papers at numerous conferences in the US and Europe on a variety of subjects including RCM, Human Error, Change Management, work execution and Procedure Based Maintenance. 
He founded Blue Sky Reliability Consulting LLC in 2013. Blue Sky works with select clients to deliver facilitation and training services and  specializes in RCM, RCA and PMO.

September 6, 2017: Leveraing Images in Your Work Management

Communication is often lost in our work order process and images have the potential to increse the efficiency of communication.  This presentation will review some of the techniques that you can leverage images to improve communication between different functions in the work management process.  

About the Presenter

Paul Crocker is a 23-year employee of Kansas City Board of Public Utilities (BPU). He holds a Bachelor of Science in Network and Communication Management, is a Kansas Department of Health and Environment Class IV Drinking Water Operator, ABC Class 3 Maintenance Technologist, Certified Reliability Leader, Ultrasound Technology Leader. Paul is currently in his 9th year as Supervisor of Maintenance at Nearman Water Treatment Plant. Received 2016 Uptime Award for Innovative use of Photography for Maintenance. Paul is passionate about Asset Management and Reliability and is active in that community in conferences as a speaker and on LinkedIn. Paul is the Chair the Kansas City chapter of SMRP. Paul is Married with 3 Kids and is a lifelong resident of Kansas City, Kansas.

October 4, 2017: Implementing FRACAS in the Biotech Industry

Failure analysis tends to be a robust system in the pharmaceutical industry when it comes to quality related issues.  In this presentation, we will discuss how to complement your quality systems with robust reliability failure analysis around your maintenance and calibration program. 

About the Presenter

Michael K. Andrews has been the Sr. Reliability Engineer at Bristol-Myers Squibb, Devens, MA since 2015. A graduate from University of Rhode Island with a BS in Mechanical Engineering and Control Systems, MLT, CRL, Michael has held roles in equipment design, project management and execution, automation and field service engineering with a primary focus on Biotech.

November 1, 2017: Design for Reliability
Transitioning from initial investment to lifecycle cost.  Review  of governence structure required for a robust system. 
 
About the Presenter

Marie Getsug of Jacobs Engineering Group, Inc. is a Program Manager of the Asset Management Group (AMG) with a focus on Design for Reliability (DfR), Reliability Centered Maintenance (RCM) and strategic Maintenance & Reliability (M&R).  Marie is an experienced maintenance and reliability (M&R) subject matter expert with 30 years of experience in multiple industries including serving as the M&R Manager for four Fortune 100 Companies. Areas of expertise include developing and optimizing M&R programs, predictive technology practices, Design for Reliability (DfR) and M&R excellence programs that integrate M&R specifications, standards & experience commencing with the concept and design phases of the capital project process. Marie is formally trained and certified in Reliability Centered Maintenance (RCM2), Project Management (PMP), Total Productive Maintenance (TPM), vibration analysis, ultrasound, lubrication, thermography and Root Cause Analysis (RCA). She is a passionate teacher of reliability concepts. Marie leverages existing programs and strategies with best practices while integrating cGMP regulatory requirements and ISO 55000 Asset Management standards. She specializes in creating and executing assessments and designing programs with a strategic plan, roadmap, business case and ROI.

December 6, 2017: Leading Reliability with Vision
Reliability is a culture and culture needs many things to sustain.  Structure and robust systems can help maintain culture, but vision is needed in order to establish a reliability culture.  Individuals need to see what is bigger than themselves and believe that it is possible before they sign up for the journey associated with any culture change.  This presentation will explore some of the ideas around setting a vision within the context of reliability. 
 
About the Presenter

George Williams is the Director of Asset Management for B Braun Medical US. He has a Master’s Degree in Reliability Engineering from Monash University, obtained CMRP in 2003, is a CRL, and Instructor for the University of Wisconsin’s Maintenance Management Certificate Program since 2009.  George was the 2016 CMRP of the year recipient.  George is an active member of the reliability community having presented at a variety of conferences including SMRP, contributed or authored magazine articles and published content, and is active member of SMRP Pharma & Biotech SIG, Maximo Life Sciences User Group, and the Association for Asset Management Professionals.


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