Luis Montes de Oca

Morrisville,NC *****

Phone: Mobile 787-***-****

Email: ac0vm9@r.postjobfree.com

SUMMARY PROFESSIONAL PROFILE

A highly skilled and motivated professional with over 20 years of diverse hands-on experience with Pharmaceuticals, Biotech and Medical Devices industries. Background in Information Technology, Computer Systems Validation and Manufacturing Execution Systems. Worked under Consent Decree commitments in pharmaceutical industries. Extensively involved in all aspects of the Validation lifecycle, Remediation, CAPA and Change Control management, Validation protocol generation and execution, Equipment Qualification (Laboratory/Manufacturing/Packaging), SOPs generation, Auditing, Computer Systems Administration. Trained and extensive knowledge in FDA regulations (GxP, 21 CFR Part 11, etc.), GAMP and other compliance guidelines. Bilingual (English and Spanish).

Technical Expertise in Computer Systems and Software. Installation Windows Servers and workstations, Network infrastructure support(Cisco), Microsoft Office suite, SQL Database query, Novell operating system, MES, PAS-X, SAP, Electronic Batch Records, Master Data, Ethical Hacking Security, Backup systems (Netbackup, VERITAS, Backup Exec), HMI SCADA, PLC, Network Barcode Printers, Avaya Telephone system, Cabling, Ethernet wiring, Remedy and Vitalize service helpdesk solution.

WORK EXPERIENCE

Computer System Validation Consultant

March-2017 at Current

Lonza Biologics, Portsmouth, NH

Senior IT/Automation MES Consultant

Dec-2013 at Feb-2017

Bristol Myers Squibb, Devens, MA

Responsibilities:

Computer System Validation for DeltaV.

Change Control revision for Delta V and Syncade (eBR) implementation.

Installation and Verification protocols execution for DeltaV

Risk Assessment protocol execution for eBR changes

Responsibilities:

Delta V upgrade, part of the infrastructure team, performing qualification and configuration of the manufacturing hardware (Servers, HMIs, Laptops and wireless devices)

Perform hands-on fixes, including planning, installing and implementing software upgrades and configuring systems and applications.

Responsible for the administration, installation, configuration of the Core Manufacturing Execution System (MES) DeltaV, Syncade, Discoverant, OSI PI Historian Applications.

Provide on the floor operational support.

Perform user Active Directory administration and security configuration.

Configuration of network barcode label printers on Print server.

Perform system configuration to Thin Manager application (HMI, Thin Clients and wireless laptops)

Performed re-Qualification of the Oracle GoldenGate system

Performed validation cycle of the PI Historian server

Perform Qualification of GMP equipment and devices, commission and Decommission.

Perform Periodic Review of the manufacturing systems

Creation and revision of IT SOPs and work instructions in the DCA documentation system

Working with Quality System eCC Trackwise change control

Support Laboratory equipments using change control and qualification.

Creation of validation protocols (IQ/OQ/Data Migration/Reports)

Network and IT system change management configuration(windows servers)

Execution of SQL Database query

Senior IT Consultant

DCS Automation

Sep-2013 at Dec-2013 Biogen, Cambridge, MA

Responsibilities:

Provide Delta V system administration.

Provide technical engineering support of the users in the manufacturing environment.

Update Delta V system documentation (Design specification, user account management)

Perform Delta V User Periodic Review

Senior IT Analyst Consultant

MES Project

Mar-2011 at Jun-2013

McNeil Consumer, Las Piedras, Puerto Rico (Orvis Validation.)

Responsibilities:

Provide technical validation support of process, equipment upgrades/replacements and modifications in the manufacturing environment.

Provide diverse validation support in the design, implementation, and test of the MES (PAS-X) application through the system development lifecycle.

Manages the day to day system administration of the MES application.

Develops, modifies, applies, and maintains standards for processes, systems and procedures.

Develops, analyzes, modifies and executes software test plans and procedures.

Experience working in Consent Decree manufacturing environments.

Perform challenges to Werum PAS-X System after patches installation.

Lead training and ensure effective knowledge transfer to the power users and end-users responsible for final use of the application to ensure compliance to GMP systems.

Execution of the PAS-X security and Part 11 compliance test scripts.

Implement fix and patch releases as required through the change control process.

Provide Technical support to the Electronic Batch Record (Werum PAS-X)

Configuration of Thin Clients, Zebra printers and Toledo ID30 Scales within PAS-X application.

Werum PAS-X Security Configuration and System administration

Experience with EDMS system to create, edit, modify, obsolete Procedures and change control. Additional the electronic approval routing process.

Mercury R6 SAP hardware implementation, including wireless and RF devices.

Perform Installation Qualification activities of Mercury SAP R6 equipments.

Development of Procedures for Mercury SAP R6 devices.

Manages technical/service relationship between the client and vendors

Business Technology Specialist (Consultant)

Periodic Review Project

Apr-2010 at Dec-2010

Pfizer Pharmaceutical, Guayama-Carolina, P.R

(RCM Technologies)

Responsibilities:

Conduct Periodic Review of the validated systems and protocols to ensure compliance.

Identify GAPs, make recommendations and continuous improvement.

Determine Remediation Plan.

Perform reviews and verification of all validated documentation to ensure criteria and results are accurate and comply with regulations.

Prepare Periodic Review summary report.

EDMS Electronic Documentation Management System revision

SAP_SCC System Change Control revision.

IM Compliance Support -

Record Retention Management Project

Nov-2009 at Jan-2010

Pfizer Pharmaceutical, Caguas, Puerto Rico

(RCM Technologies, Inc.)

Responsibilities:

Evaluate IT local systems to determine if they support and comply with Electronic Records Retention policies eRIM.

Determine GAPs in records retention functionalities.

Determine remediation requirements.

Work with the Information Technology group and/or vendor to determine estimates for system/program changes to address remediation requirements.

Coordinate data gathering meetings with IT and/or business process owners.

Perform data gathering, assessments, follow-ups to meet required due dates.

Sr. CIM Process Support-Consultant

Engineering Department

Jan-2009 to Nov-2009

Ethicon LLC,San Lorenzo, Puerto Rico

(RCM Technologies, Inc.)

Responsibilities:

Create and review computer system validation protocols

Assessment on manufacturing machines (FAS/MAS) for CAPA issues

Information system support to the validated computers.

Computer system validation lifecycle for barcode printers.

Windows Vista migration (Velocity Project) on GMP validated computers (Functional, IQ,OQ and SOP revision)

Batch print data validation upgrade to Windows Vista

Label View upgrade to Windows Vista.

SAP Master Data Support -Consultant

SAP ePES Project

Feb-2008 to Dec-2008

Janssen Ortho LLC, Gurabo, Puerto Rico

(ITC&S, Inc.)

Provide technical support to the ePES (electronic Process Execution System) Electronic Batch Record SAP interface

Provide support to the SAP master data module

Engineering change management and change control creation

Manufacturing/Packaging master recipe creation/maintenance

Creation bill of material (BOM)

Maintenance usability layer of ePES system

Process step repository maintenance

Experience working in One Source and Microsoft Office solution

Senior Computer System Validation - Consultant

MySAP ERP Project

Apr-2007 to Dec-2007

Cesar Castillo Inc. Guaynabo, Puerto Rico (VALCOA, Inc.)

Responsibilities:

Development deliverable documents for SAP software (Master Validation Plan, User Requirements, Functional Requirements, Installation Qualification, Operational and Performance Qualification).

Provide and facilitate the appropriate information to the power users.

Follow System Development Life cycle (SDLC) for SAP implementation.

Computer system validation for SAP sale and distribution (SD), material management (MM) and warehouse management (WM) modules.

Executes validation and qualification protocols, test scripts and generates final/summary reports.

Development of information technology procedures (Security, Disaster Recovery, Change Control, Good Documentation Practices)

Information Technology infrastructure audit (COBIT guidance).

Leads/trains cross-functional teams, with special support to IT, in compliance and validation activities

SAP Train and knowledge transfer for power users and IT resources for the qualification execution

Develops and communicates project timeline and status.

Computer System Validation Consultant

SAP Project

Nov-2006 to Feb-2007

Bristol Myers Squibb, Manati, Puerto Rico (TARATEC)

Responsibilities:

Integration wireless equipment with SAP interface.

Develop and execute protocols for access point, hand held and barcode printers.

Execution ERP analysis, testing and implementation wireless SAP system.

Wireless equipment configuration.

Writes protocols that challenge the critical parameters related to the installation, operation and performance of the related wireless system for SAP implementation.

Develops and communicates project timeline and status.

Training and coaching others.

Development Standard procedures and work instructions.

Senior Computer System Validation Consultant

Network Project

Jan-2006 to Sep-2006

Wyeth Pharmaceutical, Guayama, PR. (TARATEC)

Responsibilities:

Installation and Operational Qualification execution for Network communication Rooms.

Information system infrastructure support.

Create and update network drawings (Visio).

Development and update standard procedures and operational instructions.

Hardware and software inventory.

Computer System Industrial Automation Consultant

Project Validation

Jun-2005 to Dec-2005

Wyeth Pharmaceutical, Carolina, Puerto Rico (TARATEC)

Responsibilities:

Installation/Operational commissioning and qualification for manufacturing formulation tanks.

Develop and execute validation documents for Process Control (IQ, OQ, deviations and summary reports).

Mechanical Installation Qualification and P&ID.

Process Control System, HMI, CIP, and SIP.

Operational Qualification of transfer tanks, PCS to control glycol system and water temperature with calibrated thermocouples and Kaye Validator 2000 equipment.

Development of cleaning validation and media for manufacturing holding tanks.

Train internal resources for qualification execution

Develop discrepancy and summary reports.

Consultant’s supervision.

Computer System Validation Consultant

IM Compliance Remediation Project

Jan-2005 to Jun-2005

Cordis, Miami, Florida (TARATEC)

Responsibilities:

Remediation of legacy and new system in order to comply with Cordis and FDA regulations.

Generation of System Life Cycle documents such as: GAP assessment, GxP assessments, validation plans, remediation plans, retirement plans, summary reports, and system specification (DS, FS, CS), Protocols (IQ, OQ, PQ) as per Cordis methodology.

Computer system validation assessment and remediation plan development for manufacturing and business systems to assure compliance with regulatory requirements (21 CFR Parts 11, 210, 211 and 820), new corporate requirements and industry best practices (GAMP4)

Generate requirements traceability matrix

Senior System Analyst

Jan-1998 to Nov-2004

Bristol Myers Squibb,

Manati, Puerto Rico

Responsibilities:

Responsible for Network and Data Center Operations. Also provide support to computer validation team for Data Center and Network Qualification

Installation of the local network servers and client workstations.

Support network infrastructure solving software configuration problems and PC technical support to end-users on qualified applications within SLAs.

IS support for business operations through software/hardware implementation and upgrades.

Maximo Installation and configuration.

Maintenance centralized servers, network data and voice communications.

Document network/system architecture, configuration settings, and procedures

Maintain and monitor up to date Data Backups, security measures, and system uptime.

Desktop and Infrastructure Inventory Management (Asset Inside)

Support Definity Private Branch Exchange (PBX), Call Accounting, dedicated data, ISDN and phone lines.

Experience with voice and data connectivity. Knowledge of TCP/IP protocols and systems management server applications

Experience with Cisco routers, switches, firewalls and VPN technology

Responsible for designing and developing computer procedures to assure compliance with internal and external audits and regulations.

Other responsibilities include providing support to manufacturing applications BPCS/ROPICS systems

Train users and IT resources in new technologies.

Supervise temporary and contractor employees.

Operational experience supporting a 24x7 environment

Operation Specialist

Oct-1992 to Jan-1998

Dupont Merck Pharmaceutical,

Manatí, Puerto Rico

Responsibilities:

Provide End user support to GMP Manufacturing computers

Responsible for auditing, evaluating, analyzing, documenting, training and release of production batch folder documentation (applying Good Documentation Practice).

Production Quality Assurance in Compression, Granulation and Packaging areas.

Cleaning Room Quality Assurance inspection.

Production scheduling requirements in accordance with Planning and quality standards.

Production operator responsible for tablet compression and granulation.

Compliance with CGMP, OSHA and other FDA regulations.

Knowledge of BPCS, MRP application, shop floor control and inventory modules.

EDUCATION

American University of Puerto Rico 1994 – 1998

Universidad del Este Puerto Rico 2003 – 2004

American University of Puerto Rico- 1993 – 1997

Advanced Microcomputer Institute, PR – 1996

Bachelor Degree in Information System, Summa Cum Laude

Associate Degree, Cisco Networking Certification (CCNA)

Assoc. Degree in Information Science

Assembly and PC Repair

Professional Affiliations Honors and Certifications

Network+ CompTia Certification

Microsoft Certified Technical Specialist (MCTS-2008)

A+ Comptia Certification, 2003

NCA Novell Certified Administrator, 2003

MCP Microsoft Certified Professional, 1999.

American Society of Quality.

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