Holger Mettler
Director Instrument & Control Gbu Bls Continental Europe @Exyte
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WORK HISTORY
Director Instrument & Control Gbu Bls Continental Europe @Exyte
Stuttgart, DE
Management/Senior IT and Automation Consultant and coordinator with a proven track record in managing Digital Automation, Industrial IT and Cyber Security projects in global, multi-cultural & regulated industries (Biotech & Pharma and Medical Devices). • Head of the Instrument & Control team in Exyte Europe.• Long-standing experience in the pharmaceutical, medical device and bioprocess industry with a focus on: • Distributed Control Systems (DCS) and SCADA Systems, Manufacturing Execution Systems (MES), LIMS Systems, SAP systems, Cloud• Laboratory & Quality Control systems (HPLC, GC)• IT QA Policies, VMP, SOPs and IT quality systems• Operational and IT Security and Informations Security Management Systems (ISO 27001, KRITIS)Pharma 4.0, Smart Factries • Experienced Auditor for EU GMP Annex 11 and FDA 21 CFR 11. • Certified ISO 17025 and ISO 27001 Lead Auditor• Certified IT Project Manager• Certified Medical Device Regulation Expert.• Well experienced in all ISPE GAMP guides as a trainer.• New Cyber Security Concepts for automated industrial control and production systems (ISO 27001, IEC 62443). IT Security and Cyber Security Consulting• IT Security Audits, IT Sicherheitsgesetz, KRITIS § 8a Audits
EDUCATION
Technische Universität Berlin
Master's degree, Communication Technology, Computer Science and Bionics and Evolution Technology,
SKILLS
ABOUT HOLGER METTLER
Director Instrument & Control in Continental Europe at Exyte. Senior Management Consultant with a strong knowledge in IT, OT, Cyber Security, Digital Transformation and project management. Specialized in OT technologies (PCS/DCS/MES/EMS) and IT/OT security measures for pharmaceutical and biotechnology productions. Your expert for Industrial Control and IT systems in pharmaceutical manufacturing, Computer System Validation, Data Integrity and Cyber Security in the life science area.Subject Matter Expert in the in the are of Industry 4.0, Pharma 4.0, Smart Factory and Artificial Neural Networks.Senior IT and CSV Manager with a proven track record in managing ICS automated systems, IT quality & GxP compliance and delivering complex data integrity projects successfully in global, multi-cultural & validated environments. Former Head of a excellent team in the area of IT quality and CSV service team at the Exyte group.Long-standing experience in the pharmaceutical, medical device and bioprocess industry with a focus on Distributed Control Systems, Manufacturing Execution Systems, Cloud Solutions, Automation, DCS, PLC, LIMS Systems, SAP systems, Laboratory & Quality Control.Generate IT QA SOPs and IT quality systems. EU GMP Annex 11 and FDA 21 CFR 11 Auditor. Well experienced in all GAMP guides as a trainer.Cyber Security Concepts for automated industrial control and production systems (ISO 27001, IEC 62443). IT Security and Cyber Security Consulting.Projects:Implementation of global automation standards including the development of site-specific automation concepts and solutions.Development of project plans, URS, FRS, and commissioning documents for new automated systems.Develop strategic initiatives and present best practices and key industry trends, including developing and delivering new and unique approaches to automation and digital.Develop, automate, and validate data management processes.Responsibility for the optimization, standardization, and upgrade of existing automation technology and process control.Cyber Security Concepts for the implementation and administration of the access and virus protection, including back-up and disaster recovery plans for the industrial automation systems.Read the full article here: https://lnkd.in/e4UxYbyw#GMP#Computer System Validation#GAMP 5# 21CFR11#Cyber Security#Pharma 4.0#Smart Factroy#LifeScienceIndustry #PlantQualification #ProcessValidation
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