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John F. Muench

John F. Muench                        30 Fieldstone Trail,                 C: 862-222-4535                     jmuench@ptd.net
                                       Sparta, NJ 07871                    H: 973-770-8934
SUMMARY
• IT Manager, PM, Solution Architect: many years BioPharmaceutical, Telecommunications, Consumer Goods, Health IT.
• Vast professional IT experience (systems, storage, networks, software, auditing): flexible self starter to make major
   contribution to organizational objectives while expanding my leadership, professional, and IT skills in a team environment.
• Diversified IT work, including 11 years in application systems development and deployment (emphasis in data base, networks,
   release management), SC-DR, supply chain (Sales, Logistics, VMI EDI), 17 years systems/project management.
• Involved in all phases of system development life-cycle (SDLC), compliance, evaluation, analysis, design, troubleshooting,
   architecture, infrastructure, engineering, QA and FDA Audits, interaction with users, vendors and management at all levels.
• Create innovative IT solutions for complex systems; provide QA, test/DR planning, SDLC/VLC/ITIL compliance guidance.
• Excellent at Process Improvement, cost savings/avoidance, operational efficiency, proactive issue identification/resolution.

EXPERIENCE
VMware, Inc (IT Software Products, Professional Services Organization), Palo Alto, CA via Sparta, NJ         Dec 2010-Present
Implemented vCenter Operations (vCOps) Enterprise system for Global IT Enterprise Application Performance Management.
    Senior Consultant (Solution Architect, Systems Engineer)
• Install, configure and customize vCOps Performance Analytics software (vCenter Operations) to enable global health view of
    IT enterprise (from 1st Level IT to Top executives), allow IT to be proactive, determine root cause of issues, predict and help
    prevent problems, and add value to Business (minimize down-time and enable Strategic IT and Business alignment).
• Built customer specific vCOps applications and dashboards to leverage data from existing monitoring systems (EMC Smarts,
    NetIQ, OEM, vCenter, BAC, Hyperic, Hobbit, Vital, etc) for Proactive/Predictive alerts on KPI events before problems occur.
• Train client IT Global Services staff on vCOps (Integrien Alive) product, plus related applications and dashboards I created.
• Defining vCOps supermetrics for KPIs on major/large Applications (Exchange 2007, ESRS, ELMS, PowerLink, etc).
• Tuned vCOps to collect over 4 MM metrics/5 mins for real-time Health/Alerts on over 35,000 IT resources for a global client.

Johnson & Johnson (Pharmaceutical & Consumer Products – IT Services via SGS Consulting), Raritan, NJ              Sept-Oct 2010
Assisted with Transformation of J&J IT organization from a Regional Business Unit IT Structure to IT Shared Service Global
Enterprise One I/T Organization, via transition and deployment planning initiatives as part of Global Services ITS organization.
    Global Program Manager - IT Consultant
• Developed Global Deployment Plan and Approach (draft) PowerPoint presentation to implement new SaaS based Iris (Service-
    Now) system to replace existing ITSM (BMC Remedy) and non-ITSM (SAP Solution Manager, etc.) systems.
• Reviewed/cross referenced tasks in Iris Project Master Plan with Global Services Iris Program Deployment Plan, identified
    missing pieces, and suggested broader and more comprehensive Global Services solution approach (using ITIL framework).
• Participated in many IT management working sessions to develop Global Program and transition plans with Global Release
    Leads (representing J&J Regional Business Units) and encourage integration planning/coordination to prevent more delays.
• Contract ended due to J&J decision to put Deployment portion of Global Program (I was managing) on Hold while others
    revise master plan and continue software release prep (months of delays; Iris couldn‘t be ready for 2010 deployment start).

MCS Consulting (IT Services specializing in Architecture, Validation, Compliance Advice), Sparta, NJ     Oct 2009- Present
Provide advisory services on IT architecture, planning, management; esp IT solutions needed for FDA Compliance initiatives.
    Owner – IT Consultant
• Impart guidance on perfoming 21CFR Part11 Asessment/Remediation (especially planning, organizing, and regulations).
• Provide IT Architecture advice (SAN, USP, single pane storage management, PaaS, SaaS, Non-Functional requirements).
• Supply guidance on perfoming Computer Systems Validations (esp Master Plan contents and validation strategy concepts).
• Advise on new IT (Cloud, Pega, VMs, Alive) for Business Process Management (BPM), cost reduction, improved efficiency.
• Proffer advice on expanding knowledge, broadening IT expertise, developing personal marketing strategy, selling skills.

Conwood Company (Smokeless Tobacco Products - IT via Millennium Search), Memphis, TN August 2009-October 2009
Architect, plan, manage and help implement IT infrastructure solutions needed for IT SC-DR FDA Compliance initiatives.
   Disaster/Recovery (DR) SME and Project Manager – IT Consultant
• Performed Gap Analysis and mapping of Production-DR environments to determine DR IT solution requirements.
• Defined Project Plan of tasks needed to take client to needed DR site mirrored state, issue tracking, weekly status reporting.
• Proposed multi-site IT solution to allow client RTO/RPOs to be met for each application per Business Impact Analysis.
• Provided budget, Appropriation Requests for IT hw/sw needed for proposed solution (servers, VMs, switches, storage, etc).
• Built Test lab: Vet solution (VMware, iSCSI/NAS, Double-Take replication, Exchange, SQL, Citrix, VPN, SAP, EDI, etc).
• Developed full DR Technical Recovery Plan documentation to work hand-in-glove with Business Continuity documents.
                                                                  1
John F. Muench
• Worked with cross-functional teams to document application to IT infrastructure process relationships/dependencies.

Celgene (BioPharmaceutical - Enterprise Busines Systems IT via Patel Consulting), Warren, NJ              Jan 2009-April 2009
Architect, plan, manage, implement IT System Architecture solutions needed to support Global IT clinical SC-DR initiatives.
    Systems Architect & Disaster/Recovery (DR) Expert – IT Consultant
• Provide complete Systems Architecture and Service Continuity (SC) support and advice for SC-DR projects and solutions.
• Defined Systems Architecture and multiple site Solution Design for global SC Program projects (NJ-CA-Switzerland).
• Developed DRP Test Plan and related IT Checklist to advise and guide IT and Project teams (30+ core members) globally.
• Devised process to map Production, DR and Validation environments to identify gaps then led IT team(s) to resolve them.
• Did Web based testing (Intranet, Internet, VPN interfaces) to identify and address issues that could prevent SC-DR success.
• Served as Technical Team Lead to prepare for and execute multiple successful DR Exercises (IT Dry Run and User Tests).
• Explained user, Firewall, Netscaler Load Balancer, ALSB Ent Svc Bus, Weblogic App Server, Oracle/Dataguard interactions.
• Wrote/reviewed SC Investment Proposal, Project Charter, Plan, BIA, Master Exercise List, test scripts, Generic DRP Plan.

Novartis (Pharmaceutical Development IIS&I Global IT Org via Patel Consulting), East Hanover, NJ           July 2008-Dec 2008
Architect, plan, manage and implement IT Infrastructure needed to support Global IT clinical system solutions.
    Infrastructure Architect – IT Consultant
• Provided complete Infrastructure Architecture support for upcoming Development Informatics projects/solutions.
• Did Infrastructure Architecture Design for ADVANCE Program world wide (OC/RDC for ~70,000 users in 60 countries).
• Worked with/manage Project teams, Oracle, IBM and Novartis groups to design/plan development, test, production systems.
• Built Oracle Clinical Development OC/RDC/TMS System(s) as global team using virtual and SUN servers with IBM SAN.
• Created Specified Infrastructure Architecture Visio diagrams for Novartis Test/DR/Production Oracle Life Science systems.
• Wrote System Design Spec on Solaris DB, Windows App/Web servers, network/system building blocks architecture/function.
• Got concurrence from vendors (IBM, SUN) and Novartis DR/LAN/WAN/Web review teams that global design is sound.
• Confirmed network security/performance aspects of HA design to include WAF, load balancers, firewalls, clustering, etc.
• Created and used PowerPoint Presentations to present IT solutions, schedules, and financials to stakeholders and others.
• Defined Advance Program CDMS multi-site Disaster/Recovery plan for OC/RDC Solution Concept and SDS documents.

Aurora Health Care (13 Hospitals, 140 Pharmacies, 140 Clinics via SPR Consulting), Milwaukee, WI          April-June 2008
   Ensure availability/performance of large Alpha/VMS clustered systems, related HP and EMC storage, plus AIX interfaces.
   Lead Systems and SAN Storage Engineer – IT Consultant
• Manage 24 Alpha/Itanium VMS systems (GS1280s, GS160s, ES clusters) and 200TB of HP EVA and EMC DMX storage.
• Manage 115TB HP EVA5000/EVA8000 RAID storage via CommandViewEVA, CISCO MDS 9509 switches, Zones.
• Manage/mask 230TB DMX3/DMX4/CX3/CX700 storage via EMC TimeFinder, ECC, SMC, CISCO MDS switches.
• Assist with Cerner Oracle DB migration (9.8 TB/instance) from VMS/HP-EVA to AIX/EMC-DMX3/DMX4 system/storage.
• Handle HP ESL712e Data Protector backups, fixed issues, update Disaster/Recovery plan/docs for D/R test (at IBM hot site).

PPD (Pharmaceutical & Medical Device CRO Lab via Technisource Consulting), Morrisville (RTP), NC May 2007-Oct 2007
   Ensure availability/validated state of VMS clustered systems, storage plus VMS-Unix-Windows interfacing worldwide.
   Sr. Systems/Network Admin/Engineer Consultant
• Wrote,executed IQ/OQs for qualification and compliance of GxP systems for multi-$MM US Army business expansion.
• Improved ABS/MDMS (Archive Backup System) configuration and multi-site Disaster/Recovery implementation.
• Enhanced VMS-Unix NFS host interface and defined user and export proxies to enable automated Oracle SAS transfers.
• Ensure reliability and availability of Pathworks and VMS supported storage resources for thousands of SAS users.

Schering-Plough (Pharmaceutical R&D via ThinkCentric Consulting Services), Lafayette, NJ           March 1999-Dec 2006
    Ensure availability/functionality/performance/validated state of GxP VAX, Alpha/VMS, and HP/UNIX Global IT systems.
    Infrastructure Architect, Sr. System/Security Admin/Manager, Technical/Compliance Advisor, Project Manager, Network
    Consultant, SAN Engineer
• Architected/planned/built multi-node distributed cluster with dual fabric, HP RAID arrays, Fibre Channel SAN switches (per
    VSD, URS/FRS, System Design Spec, many IQ/OQs, PQ/UAT, VSR SDLC docs; on which I was writer/reviewer).
• Key contributor to LAN/infrastructure upgrade to create Y2K compliant LAN environment; replaced equipment with
    Cisco3640 routers and then by Cabletron/Digital MultiSwitch900 DECHubs and DECserver900GM terminal servers.
• Helped fix many LAN/WAN issues, replace faulty Cisco switches/routers, plan/install GbE Fiber LAN, 1000BaseT servers.
• Performed Config Management/Release Control: ensure applications tested/validated before moving to production.
• Trained Compliance Analysts and Oper Quality Reviewers on use of SOPs and technical/procedural system remediation.
• Provide advice/input to RIS/GIT Infrastructure Storage Area Networking (SAN) and Enterprise Backup committees.
• Provide answers for Corporate, IT, QA & FDA Audits; develop processes/SOPs/WIs for compliance with GxP Laws.
                                                                   2
John F. Muench
• Reviewed, evaluated COMDISCO/Sungard vs. IBM D/R hot site contract proposals: saved S-PRI ~$1MM over 3 years.
• Advise management on technical and GLP/21CFR11 compliance, efficient IT operations, improved customer support.
• Project Manager to retire VAXcluster and migrate legacy applications to newer Alpha system (saving $53K/yr).
• Assist/advise in capacity planning, application upgrades/migrations, related system/Oracle performance improvement.
• Revised HP Service Contract and created more efficient, direct payment process (reducing maintenance costs $67K/year).


EDUCATION B.A., Computer Science, Rutgers University, New Brunswick, NJ        GPA 3.0                         1995
          AAS, Data Processing, SUNY Morrisville, Morrisville, NY              GPA 3.1
          Quality Assurance FDA cGxP & Inspection Training (Schering-Plough)                 1999, 2000, 2002-2006
          21CFR Part11 (Electronic Records & Electronic Signatures): Awareness and Applied Training            2002
          Schering-Plough SPRI 05 and WQS 10,134 Computer System Validation               October 2002, March 2006
          SPRI DS&M (Drug Safety & Metabolism) & GIT Change Control-Problem Tracking             Nov2003-Mar2004
          SPRI GIT Enterprise Shared Services (ESS) SOW/IDL Infrastructure Lifecycle/Work Planning        Sept 2004
          Multiple VMS, UNIX, WNT System Administration courses and training certificates.
          BCFP (Brocade Certified Fabric Professional) SAN certified.                                      Feb 2007
          Pursued CISA (IS Audit) certification (successfully passed rigorous CISA exam).

Memberships and Professional Associations (present and past):
HP-ITRC, SearchStorage.com, Validation Matrix group, IASA: The Global IT Architects, PMI - Project Management, Institute,
GxP / HIPAA / HITECH - Regulated IT, 21 CFR part11, Business Continuity and Disaster Recovery Professionals, Business
Continuity Management & Risk, Storage Professionals, The IT Architect Network, VALIDATION EXPERTS, The ITIL Group,
Cloud Computing, Pega PRPC Professionals, Pega Architects, BPM Group, BPM Guru.
Former: ISACA, NJ-ISACA, APDA, DECUS, DEC/EDI Users Group (co-founder), NA-IUA (Ingres Users Association).


COMPUTER SUMMARY
 Hardware: HP VAX/Alpha/Itanium VMSclusters, Storage Area Networking (SAN), HP StorageWorks and EMC RAID Arrays,
             Brocade Fibre Channel Switches, HP and SUN servers, HSG/HSV disk controllers, PCI-SCSI FibreChannel and
             Host Bus Adapters, IBM/Dell/HP PC’s, MACs, DECnet/SNA Gateways, RS6000s, CISCO routers/switches, VPN,
             Citrix Netscaler switches and servers, HA cluster system configurations, printers, tape drives, wireless routers, WI-
             FI devices, firewalls, modem banks, USB devices (cameras, disks, FAX, etc.).
 Software:   vCOps, CV-EVA, ECC, SMC, DECnet, LAT, WWIDMgr, TCP/IP, AdviseIT, Visio, System Detective AO,
             PathWORKS, NFS, INGRES, ORACLE, SYBASE, SQL, SMTP, BASIC, PASCAL, C, FORTRAN, MicroSoft
             Office (Word, Excel, PowerPoint, Outlook), MS Project, MacProject, MacDraw, HTML, WebLogic, Exchange,
             NetScape, ERwin, IExplorer, DEFT, Inter•Poll, AXENT (Security Guard), HP Data Protector, ABC/ADSM (TSM),
             ABS, CommandView, DCL, ALSB, LDAP, AD, RSA, VMware, Lotus Notes.
 Op. Sys.’s: VAX-Alpha-Itanium/VMS, MS/Windows (Windows Server 2008 R2, Windows 95, 98, NT, XP, Vista, 7),
             MS/DOS, UNIX (HP-UX, AIX, Solaris, AT&T), RHELinux, SAN OS, FOS, Mac OS, HP BASIC.




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Muench,John Res13 Jun2011 It Pm Arch Eng Dr San Compliance Short Word97 2003 Version (25 Jun 2011)

  • 1. John F. Muench John F. Muench 30 Fieldstone Trail, C: 862-222-4535 jmuench@ptd.net Sparta, NJ 07871 H: 973-770-8934 SUMMARY • IT Manager, PM, Solution Architect: many years BioPharmaceutical, Telecommunications, Consumer Goods, Health IT. • Vast professional IT experience (systems, storage, networks, software, auditing): flexible self starter to make major contribution to organizational objectives while expanding my leadership, professional, and IT skills in a team environment. • Diversified IT work, including 11 years in application systems development and deployment (emphasis in data base, networks, release management), SC-DR, supply chain (Sales, Logistics, VMI EDI), 17 years systems/project management. • Involved in all phases of system development life-cycle (SDLC), compliance, evaluation, analysis, design, troubleshooting, architecture, infrastructure, engineering, QA and FDA Audits, interaction with users, vendors and management at all levels. • Create innovative IT solutions for complex systems; provide QA, test/DR planning, SDLC/VLC/ITIL compliance guidance. • Excellent at Process Improvement, cost savings/avoidance, operational efficiency, proactive issue identification/resolution. EXPERIENCE VMware, Inc (IT Software Products, Professional Services Organization), Palo Alto, CA via Sparta, NJ Dec 2010-Present Implemented vCenter Operations (vCOps) Enterprise system for Global IT Enterprise Application Performance Management. Senior Consultant (Solution Architect, Systems Engineer) • Install, configure and customize vCOps Performance Analytics software (vCenter Operations) to enable global health view of IT enterprise (from 1st Level IT to Top executives), allow IT to be proactive, determine root cause of issues, predict and help prevent problems, and add value to Business (minimize down-time and enable Strategic IT and Business alignment). • Built customer specific vCOps applications and dashboards to leverage data from existing monitoring systems (EMC Smarts, NetIQ, OEM, vCenter, BAC, Hyperic, Hobbit, Vital, etc) for Proactive/Predictive alerts on KPI events before problems occur. • Train client IT Global Services staff on vCOps (Integrien Alive) product, plus related applications and dashboards I created. • Defining vCOps supermetrics for KPIs on major/large Applications (Exchange 2007, ESRS, ELMS, PowerLink, etc). • Tuned vCOps to collect over 4 MM metrics/5 mins for real-time Health/Alerts on over 35,000 IT resources for a global client. Johnson & Johnson (Pharmaceutical & Consumer Products – IT Services via SGS Consulting), Raritan, NJ Sept-Oct 2010 Assisted with Transformation of J&J IT organization from a Regional Business Unit IT Structure to IT Shared Service Global Enterprise One I/T Organization, via transition and deployment planning initiatives as part of Global Services ITS organization. Global Program Manager - IT Consultant • Developed Global Deployment Plan and Approach (draft) PowerPoint presentation to implement new SaaS based Iris (Service- Now) system to replace existing ITSM (BMC Remedy) and non-ITSM (SAP Solution Manager, etc.) systems. • Reviewed/cross referenced tasks in Iris Project Master Plan with Global Services Iris Program Deployment Plan, identified missing pieces, and suggested broader and more comprehensive Global Services solution approach (using ITIL framework). • Participated in many IT management working sessions to develop Global Program and transition plans with Global Release Leads (representing J&J Regional Business Units) and encourage integration planning/coordination to prevent more delays. • Contract ended due to J&J decision to put Deployment portion of Global Program (I was managing) on Hold while others revise master plan and continue software release prep (months of delays; Iris couldn‘t be ready for 2010 deployment start). MCS Consulting (IT Services specializing in Architecture, Validation, Compliance Advice), Sparta, NJ Oct 2009- Present Provide advisory services on IT architecture, planning, management; esp IT solutions needed for FDA Compliance initiatives. Owner – IT Consultant • Impart guidance on perfoming 21CFR Part11 Asessment/Remediation (especially planning, organizing, and regulations). • Provide IT Architecture advice (SAN, USP, single pane storage management, PaaS, SaaS, Non-Functional requirements). • Supply guidance on perfoming Computer Systems Validations (esp Master Plan contents and validation strategy concepts). • Advise on new IT (Cloud, Pega, VMs, Alive) for Business Process Management (BPM), cost reduction, improved efficiency. • Proffer advice on expanding knowledge, broadening IT expertise, developing personal marketing strategy, selling skills. Conwood Company (Smokeless Tobacco Products - IT via Millennium Search), Memphis, TN August 2009-October 2009 Architect, plan, manage and help implement IT infrastructure solutions needed for IT SC-DR FDA Compliance initiatives. Disaster/Recovery (DR) SME and Project Manager – IT Consultant • Performed Gap Analysis and mapping of Production-DR environments to determine DR IT solution requirements. • Defined Project Plan of tasks needed to take client to needed DR site mirrored state, issue tracking, weekly status reporting. • Proposed multi-site IT solution to allow client RTO/RPOs to be met for each application per Business Impact Analysis. • Provided budget, Appropriation Requests for IT hw/sw needed for proposed solution (servers, VMs, switches, storage, etc). • Built Test lab: Vet solution (VMware, iSCSI/NAS, Double-Take replication, Exchange, SQL, Citrix, VPN, SAP, EDI, etc). • Developed full DR Technical Recovery Plan documentation to work hand-in-glove with Business Continuity documents. 1
  • 2. John F. Muench • Worked with cross-functional teams to document application to IT infrastructure process relationships/dependencies. Celgene (BioPharmaceutical - Enterprise Busines Systems IT via Patel Consulting), Warren, NJ Jan 2009-April 2009 Architect, plan, manage, implement IT System Architecture solutions needed to support Global IT clinical SC-DR initiatives. Systems Architect & Disaster/Recovery (DR) Expert – IT Consultant • Provide complete Systems Architecture and Service Continuity (SC) support and advice for SC-DR projects and solutions. • Defined Systems Architecture and multiple site Solution Design for global SC Program projects (NJ-CA-Switzerland). • Developed DRP Test Plan and related IT Checklist to advise and guide IT and Project teams (30+ core members) globally. • Devised process to map Production, DR and Validation environments to identify gaps then led IT team(s) to resolve them. • Did Web based testing (Intranet, Internet, VPN interfaces) to identify and address issues that could prevent SC-DR success. • Served as Technical Team Lead to prepare for and execute multiple successful DR Exercises (IT Dry Run and User Tests). • Explained user, Firewall, Netscaler Load Balancer, ALSB Ent Svc Bus, Weblogic App Server, Oracle/Dataguard interactions. • Wrote/reviewed SC Investment Proposal, Project Charter, Plan, BIA, Master Exercise List, test scripts, Generic DRP Plan. Novartis (Pharmaceutical Development IIS&I Global IT Org via Patel Consulting), East Hanover, NJ July 2008-Dec 2008 Architect, plan, manage and implement IT Infrastructure needed to support Global IT clinical system solutions. Infrastructure Architect – IT Consultant • Provided complete Infrastructure Architecture support for upcoming Development Informatics projects/solutions. • Did Infrastructure Architecture Design for ADVANCE Program world wide (OC/RDC for ~70,000 users in 60 countries). • Worked with/manage Project teams, Oracle, IBM and Novartis groups to design/plan development, test, production systems. • Built Oracle Clinical Development OC/RDC/TMS System(s) as global team using virtual and SUN servers with IBM SAN. • Created Specified Infrastructure Architecture Visio diagrams for Novartis Test/DR/Production Oracle Life Science systems. • Wrote System Design Spec on Solaris DB, Windows App/Web servers, network/system building blocks architecture/function. • Got concurrence from vendors (IBM, SUN) and Novartis DR/LAN/WAN/Web review teams that global design is sound. • Confirmed network security/performance aspects of HA design to include WAF, load balancers, firewalls, clustering, etc. • Created and used PowerPoint Presentations to present IT solutions, schedules, and financials to stakeholders and others. • Defined Advance Program CDMS multi-site Disaster/Recovery plan for OC/RDC Solution Concept and SDS documents. Aurora Health Care (13 Hospitals, 140 Pharmacies, 140 Clinics via SPR Consulting), Milwaukee, WI April-June 2008 Ensure availability/performance of large Alpha/VMS clustered systems, related HP and EMC storage, plus AIX interfaces. Lead Systems and SAN Storage Engineer – IT Consultant • Manage 24 Alpha/Itanium VMS systems (GS1280s, GS160s, ES clusters) and 200TB of HP EVA and EMC DMX storage. • Manage 115TB HP EVA5000/EVA8000 RAID storage via CommandViewEVA, CISCO MDS 9509 switches, Zones. • Manage/mask 230TB DMX3/DMX4/CX3/CX700 storage via EMC TimeFinder, ECC, SMC, CISCO MDS switches. • Assist with Cerner Oracle DB migration (9.8 TB/instance) from VMS/HP-EVA to AIX/EMC-DMX3/DMX4 system/storage. • Handle HP ESL712e Data Protector backups, fixed issues, update Disaster/Recovery plan/docs for D/R test (at IBM hot site). PPD (Pharmaceutical & Medical Device CRO Lab via Technisource Consulting), Morrisville (RTP), NC May 2007-Oct 2007 Ensure availability/validated state of VMS clustered systems, storage plus VMS-Unix-Windows interfacing worldwide. Sr. Systems/Network Admin/Engineer Consultant • Wrote,executed IQ/OQs for qualification and compliance of GxP systems for multi-$MM US Army business expansion. • Improved ABS/MDMS (Archive Backup System) configuration and multi-site Disaster/Recovery implementation. • Enhanced VMS-Unix NFS host interface and defined user and export proxies to enable automated Oracle SAS transfers. • Ensure reliability and availability of Pathworks and VMS supported storage resources for thousands of SAS users. Schering-Plough (Pharmaceutical R&D via ThinkCentric Consulting Services), Lafayette, NJ March 1999-Dec 2006 Ensure availability/functionality/performance/validated state of GxP VAX, Alpha/VMS, and HP/UNIX Global IT systems. Infrastructure Architect, Sr. System/Security Admin/Manager, Technical/Compliance Advisor, Project Manager, Network Consultant, SAN Engineer • Architected/planned/built multi-node distributed cluster with dual fabric, HP RAID arrays, Fibre Channel SAN switches (per VSD, URS/FRS, System Design Spec, many IQ/OQs, PQ/UAT, VSR SDLC docs; on which I was writer/reviewer). • Key contributor to LAN/infrastructure upgrade to create Y2K compliant LAN environment; replaced equipment with Cisco3640 routers and then by Cabletron/Digital MultiSwitch900 DECHubs and DECserver900GM terminal servers. • Helped fix many LAN/WAN issues, replace faulty Cisco switches/routers, plan/install GbE Fiber LAN, 1000BaseT servers. • Performed Config Management/Release Control: ensure applications tested/validated before moving to production. • Trained Compliance Analysts and Oper Quality Reviewers on use of SOPs and technical/procedural system remediation. • Provide advice/input to RIS/GIT Infrastructure Storage Area Networking (SAN) and Enterprise Backup committees. • Provide answers for Corporate, IT, QA & FDA Audits; develop processes/SOPs/WIs for compliance with GxP Laws. 2
  • 3. John F. Muench • Reviewed, evaluated COMDISCO/Sungard vs. IBM D/R hot site contract proposals: saved S-PRI ~$1MM over 3 years. • Advise management on technical and GLP/21CFR11 compliance, efficient IT operations, improved customer support. • Project Manager to retire VAXcluster and migrate legacy applications to newer Alpha system (saving $53K/yr). • Assist/advise in capacity planning, application upgrades/migrations, related system/Oracle performance improvement. • Revised HP Service Contract and created more efficient, direct payment process (reducing maintenance costs $67K/year). EDUCATION B.A., Computer Science, Rutgers University, New Brunswick, NJ GPA 3.0 1995 AAS, Data Processing, SUNY Morrisville, Morrisville, NY GPA 3.1 Quality Assurance FDA cGxP & Inspection Training (Schering-Plough) 1999, 2000, 2002-2006 21CFR Part11 (Electronic Records & Electronic Signatures): Awareness and Applied Training 2002 Schering-Plough SPRI 05 and WQS 10,134 Computer System Validation October 2002, March 2006 SPRI DS&M (Drug Safety & Metabolism) & GIT Change Control-Problem Tracking Nov2003-Mar2004 SPRI GIT Enterprise Shared Services (ESS) SOW/IDL Infrastructure Lifecycle/Work Planning Sept 2004 Multiple VMS, UNIX, WNT System Administration courses and training certificates. BCFP (Brocade Certified Fabric Professional) SAN certified. Feb 2007 Pursued CISA (IS Audit) certification (successfully passed rigorous CISA exam). Memberships and Professional Associations (present and past): HP-ITRC, SearchStorage.com, Validation Matrix group, IASA: The Global IT Architects, PMI - Project Management, Institute, GxP / HIPAA / HITECH - Regulated IT, 21 CFR part11, Business Continuity and Disaster Recovery Professionals, Business Continuity Management & Risk, Storage Professionals, The IT Architect Network, VALIDATION EXPERTS, The ITIL Group, Cloud Computing, Pega PRPC Professionals, Pega Architects, BPM Group, BPM Guru. Former: ISACA, NJ-ISACA, APDA, DECUS, DEC/EDI Users Group (co-founder), NA-IUA (Ingres Users Association). COMPUTER SUMMARY Hardware: HP VAX/Alpha/Itanium VMSclusters, Storage Area Networking (SAN), HP StorageWorks and EMC RAID Arrays, Brocade Fibre Channel Switches, HP and SUN servers, HSG/HSV disk controllers, PCI-SCSI FibreChannel and Host Bus Adapters, IBM/Dell/HP PC’s, MACs, DECnet/SNA Gateways, RS6000s, CISCO routers/switches, VPN, Citrix Netscaler switches and servers, HA cluster system configurations, printers, tape drives, wireless routers, WI- FI devices, firewalls, modem banks, USB devices (cameras, disks, FAX, etc.). Software: vCOps, CV-EVA, ECC, SMC, DECnet, LAT, WWIDMgr, TCP/IP, AdviseIT, Visio, System Detective AO, PathWORKS, NFS, INGRES, ORACLE, SYBASE, SQL, SMTP, BASIC, PASCAL, C, FORTRAN, MicroSoft Office (Word, Excel, PowerPoint, Outlook), MS Project, MacProject, MacDraw, HTML, WebLogic, Exchange, NetScape, ERwin, IExplorer, DEFT, Inter•Poll, AXENT (Security Guard), HP Data Protector, ABC/ADSM (TSM), ABS, CommandView, DCL, ALSB, LDAP, AD, RSA, VMware, Lotus Notes. Op. Sys.’s: VAX-Alpha-Itanium/VMS, MS/Windows (Windows Server 2008 R2, Windows 95, 98, NT, XP, Vista, 7), MS/DOS, UNIX (HP-UX, AIX, Solaris, AT&T), RHELinux, SAN OS, FOS, Mac OS, HP BASIC. 3