In this role Oliver focusses primarily on the performance of the Pharma packaging lines on a global level in order to meet the challenges of Global Pharma Operations (GPO) organization. He works intensively with the site teams in order to drive best practice sharing, build necessary skills and implement optimized and standardized technical improvements. Oliver is an industrial engineer by education and joined Merck in 2014 to lead the major investment of a new packaging center for pharma in Darmstadt. Prior he joined Merck, Oliver worked for eight years in P&G Pharmaceuticals / Warner Chilcott, developing different engineering roles as Packaging Engineer, Technical Project Leader and Site Engineering Manager.
Case Study Packaging Reliablity Engineering – a global efficiency journey
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company.
Ron Reimer is currently Eli Lilly and Company’s senior reliability engineer. He developed Eli Lilly’s global reliability program along with metrics and standards. Previously to this assignment, he was the Engineering Director at Lilly’s largest bulk manufacturing plant, where his plant was awarded the Engineering Site of the Year by the President of Manufacturing. Ron also worked in other various leadership assignments in Engineering, Operations, and Maintenance. Ron has been with Eli Lilly and Company for 26 years. Prior to joining Eli Lilly, he was a nuclear submarine officer in the United States Navy. He recently retired as Captain after serving a combined 30 years of active and reserve duty. He is a graduate of the United States Naval Academy with a BS in Systems Engineering and he also earned an MBA from City University in Seattle, Washington. He is a registered Professional Engineer, a Certified Reliability Engineer from the American Society for Quality, and a Certified Maintenance and Reliability Professional from the Society of Maintenance of Reliability Professionals.
Case Study Using Weibull Analysis to Determine Optimal Calibration Intervals
Calibration inspection intervals have been historically determined by past practices and lot bracketing concerns
Current calibration data indicates that many of these intervals are too short, causing poor instrument performance due to invasive maintenance issues and other problems
Understanding the process of using a statistical method, the Weibull distribution, together with many years of maintenance data, to determine optimal calibration intervals based on equipment criticality
Eli Lilly and Company is an American global pharmaceutical company with headquarters located in Indianapolis, Indiana, in the United States. The company has offices in18 other countries. Their products are sold in approximately 125 countries. The company was founded in 1876 by Col. Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War, after whom the company was named. Lilly has approximately 38,000 employees worldwide with more than 7,900 employees engaged in research and development. The clinical research is conducted in more than 55 countries. There are research and development facilities located in eight countries and manufacturing plants located in 13 countries.
Profile 27 years of experience in the pharmaceutical industry in the areas of asset life cycle management, knowledge management, project management and project engineering.
1 July 2016 – present
a.i. Head Asset Life Cycle Management, Novartis Technical Operations, NTO Engineering, Basel Switzerland
1 Jan 2014 – 30 Jun 2016
Head Asset Life Cycle Management, Novartis Pharma, Global Pharma Engineering, Basel Switzerland
1 April 2009 – 31 Dec 2013
Head Knowledge Management, Novartis Pharma AG, Global Pharma Engineering, Basel Switzerland including the teams for Engineering Compliance and Total Productive Maintenance
1 Aug 2008 – 31 Mar 2009
Project Manager for Conceptual Design of a new production unit in Ireland (100 MCHF)
1 Jul 2007 – 30 July 2008
Project Manager for commissioning and qualification of the new Oral Solid Dosage plant NSPM in Singapore. Final plant handover and extended engineering support during the validation and operational ramp up phase of the site
1 Apr 2004 – 30 Jun 2007
Technical Project Manager for the front-end-study, design, construction and installation of a
pharmaceutical greenfield Oral Solid Dosage tablets plant in Singapore (NSPM, 180 MUSD)
1 Jan 2001 – 30 Dec 2003
Section Head for pharmaceutical projects region Basel, leading a team of 5 engineers
1 Jan 2000 – 30 Dec 2001
Project Manager for the design, installation and qualification of a thawing/ freezing facility for a biopharmaceutical product, including extension of cold storage capacities in Switzerland (12 MCHF)
1 Jul 1998 – 30 Dec 2000
Technical Project Manager for the design, installation and qualification of 5 ampoule filling lines in isolator technology incl. compounding areas, inspection lines, autoclaves, cleanrooms and infrastructure facilities in Switzerland (80 Mio CHF)
1 May 1993 – 30 Aug 1998
Project Manager for the project phases commissioning and qualification of a new development plant for sterile galenical forms in Basel, Switzerland
1 Oct 1989 – 30 Apr 1993
Discipline engineer & commissioning engineer for the design and start-up of infrastructure projects and start-up and qualification of a new production facility for APIs in Basel, Switzerland
Keynote Asset Life Cycle Management
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. The businesses of Novartis are divided into three operating divisions: Pharmaceuticals, Alcon (eye care) and Sandoz (generics). Novartis operates directly and through dozens of subsidiaries in countries around the world.
Gary Knapick, PE is the Associate Director for Facilities & Utilities at the Bristol-Myers Squibb biologics manufacturing facility in Syracuse, NY. Current responsibilities include facilities management, site infrastructure, energy conservation, and contract management for the site’s integrated facilities management (IFM) provider. Prior roles at BMS and Wyeth have included maintenance/reliability, validation, process engineering, and capital project management. His experience includes application of lean/kaizen methods, reliability transformation, contract manufacturing support, consent decree remediation, and several pre-approval inspections.
Knapick served on the steering team for the BMS Reliability Excellence (Rx) initiative and as a delegate to the BioPhorum Operations Group (BPOG) maintenance and reliability consortium. He has earned Certified Maintenance and Reliability Professional (CMRP) and Certified Reliability Leader (CRL) credentials from SMRP and AMP, respectively. He holds bachelor’s and master’s degrees in chemical engineering, a master’s degree in business administration (MBA), and a New York State professional engineering license. In 2013, he was recognized as the BMS Reliability Excellence Leader of the Year.
Case Study Integrated Facilities Management in Biopharmaceutical Settings
Outsourced Facilities Management
Integrated Facilities Management
Facilites Management Café Integrated Facilities Management in Biopharmaceutical Settings
What are the benefits of an outsourced facilities management model?
What risks need to be managed (including GMP compliance, safety, environmental, and financial)?
What compliance responsibilities belong to the service provider, and what accountability is retained by the client company?
What quality systems must be maintained (or used) by the service provider?
What typical facility service offerings could have a direct or indirect bearing on compliance?
What metrics are required in order to measure performance?
Which financial model leads to the most productive relationship?
Bristol-Myers Squibb, often referred to as BMS, is an American pharmaceutical company, headquartered in New York City.
Bristol-Myers Squibb manufactures prescription pharmaceuticals in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis and psychiatric disorders.
BMS' primary R&D sites are located in Lawrence Township (formerly Squibb, near Princeton) and Wallingford, Connecticut (formerly Bristol-Myers), with other sites in Hopewell and New Brunswick, New Jersey, and in Swords, Ireland, Braine-l'Alleud, Belgium, Tokyo, Japan and Bangalore, India.
March 2014-today Director, Head of technical Department at Ferring Pharmaceuticals
November 2012-March 2014 Engineering Manager at Protalix Biotherapeutics
2011-2012 Senior project manager - Engineering Expert at Teva Pharmaceutical Industries Ltd.
2002-2011 Project Manager at Teva Pharmaceutical Industries Ltd.
1995-2001 Maintenance manager at Teva Pharmaceutical Industries Ltd.
1991-1994 Critical systems manager at Teva Pharmaceutical Industries Ltd.
Case Study Aging facilities
What is aging facility ?
Why should we look at it?
Product, Equipment and Systems,
Technology, Control, Compliance
Recommendations / Ways to manage
Ferring Pharmaceuticals is a research-driven, biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, urology, gastroenterology, endocrinology and orthopaedics.
The company's research activities and products are connected by a common focus of providing tailored treatments that work on the body's own terms, enabling doctors to combat numerous diseases and medical conditions.
Ferring has its own manufacturing facilities in several European countries, in South America, Israel, India and China. It is also currently building new facilities in the USA. With the acquisition of Bio-Technology General in 2005, it has capabilities in recombinant biotechnology as well as more traditional pharmaceutical manufacturing.
Ferring's marketing, medical services and sales teams, led by the corporate headquarters in Saint-Prex, Switzerland, operate from nearly 60 countries and employ 5,000 people throughout the world, while treatments are available in 110 countries. This expansion has allowed Ferring to maintain a double-digit annual growth rate over the last two decades.
In the current position Francisco is Head of Production Engineering in Boehringer Ingelheim (Sant Cugat plant). He is accountable for ensuring the equipment reliability in pharmaceutical production areas and process performance in a safety and sustainable manner. Also ensuring day to day maintenance support (automation, electrical and mechanical); offering technical analysis and troubleshooting for production equipment. During the years he has held senior positions in engineering and maintenance, reason for which he has broad experience in engineering within a GMP manufacturing environment and networking throughout different plant functions/departments. Member of Global Engineering Network, involved in international projects. Member of BPE (Business Process Excellence) leading cross-functional projects. Member of management team for cross-organizational change project.
Challenge your Peers Continuous improvement culture in maintenance by applying lean management methods
the best organization in maintenance
TPM (with all the columns such as Autonomous Maintenance, Preventive, Predictive, Spare parts management, KPI definition, Reliability, early asset management, training)
Icebreaker Passing FDA Audits Successfully – Embedding of Processes in an Overall Maintenance Strategy
January 2012-today Vice President / Head of Asset Life Cycle Management at Bayer Technology Services
2001-January 2012 Vice President / Head of Process Control Technology at Bayer Technology Services
2005-2010 Head of Technology Solutions at Bayer Technology & Engineering Shanghai
2001-2005 Director / Head of Process Control Technology LEV/UER at Bayer Technology Services
1996-2001 Gerente de Administracao da Fabrica Belford Roxo at Bayer S.A. / Brazil
Bayer Technology Services, the technological backbone of the Bayer Group, is engaged in process development and in process and plant engineering, construction and optimization. This company also develops innovative technology platforms that contribute substantially to the efficiency of Bayer’s operating units.