Mansiones del Caribe calle Topacio

AD-** Box *** Humacao, PR 00791

787-***-****-Mobil

Email: acr4xx@r.postjobfree.com

Roberto D. Gormon Vázquez

OBJECTIVE

To obtain a position in the Validation and/or Engineering Project Management field where my professional expertise will help achieve company goals and provide guidance in the pharmaceutical or Medical Device industry.

PROFESSIONAL SUMMARY:

Fourteen (14) years experience in the pharmaceutical and medical device industry, where the last years has been as a Project Manager in the pharmaceutical and medical device field. Background includes bulk, solid dosage, sterile manufacturing, packaging processes, utilities, medical devices, information technology, quality and process equipment.

PROFESSIONAL EXPERIENCE

Janssen Ortho LLC – Gurabo, PR (June 2014- Present) Sr. Project Manager

Responsible for the successful execution of several projects (26) for the Manufacturing Operations department.

Evaluated and approved project implementation activities and phases completions.

Reported project progress and milestones to site’s Global Leadership Team (GLT) on a bi-weekly basis.

Business case developed for Capital Projects.

Planning and Defining Scope for On-Going projects

Activity Planning and Sequencing

AMGEN – JUNCOS, PR (January 2013- June 2014)

Project Manager

Management of 21 CFR Part 11 implementation and compliance program for manufacturing, laboratory, and facilities applications on the site (300+ Systems) to address FDA compliance corporate commitment.

Site project management and support for implementation of corporate initiatives.

Recommend new technologies as appropriate to support business operations.

Provide Organization Leadership. Ensured adherence to company policies, standards and procedures and governmental regulations.

Responsible for weekly meeting to executive directors and managers to report progress, discuss schedule, constraints, opportunities, and next steps.

Responsible for one or more medium to large projects with moderate to high complexity, with integration across several functional areas and/or organizations.

Developed and communicated project plans, schedules, cost, budget management, and progress. Provided formalized, continuing work direction and leadership to assigned team including, scheduling, assignment of work, and review of project work.

Identified potential risks and issues and made recommendations to management when escalation is required. Assesses variances from the plan and develops and implements Mansiones del Caribe calle Topacio

AD-35 Box 343 Humacao, PR 00791

787-***-****-Mobil

Email: acr4xx@r.postjobfree.com

changes as necessary to ensure project meets time, cost, and quality objectives. Established and monitored OEE metrics upon process optimization.

Designed and Implemented sustainability model for the site on Part 11 compliance. ORVISV, Corp. – HUMACAO (May 2011- December 2012)

Operations Director

Responsible for all the business operations of the PR Office. These activities included but aren't limited to business development, proposal development, budget development, hiring and releasing of personnel, project controls, accounting, etc.

Direction, management, and supervision of personnel (20+ Professional Resources), execution of accounting, proposal preparation, client development activities and Business Planning. In addition, work on client projects performing services such as: IT & Validation project management, computer system validation full life cycle, IT System Development Life Cycle, Technical and SOP documentation, Process Analysis, Equipment Qualification and Quality Reviews.

BARD SHANNON, LTD – HUMACAO (October 2009- May 2011) Sr. Project Engineer

Responsible for leading new product transfer activities directed towards commercial products and including functionally superior modifications.

Involved in all aspects of the product transfer up to moving into production and product release.

Served as a technical resource to other sectors within the division.

Responsible for evaluating and identifying project and product risks.

Developed, managed, and maintained project timelines.

Responsible for operators supervision during qualification execution runs.

Performed engineering studies to assess manufacturing production failures leading to process improvements and failures resolution.

Development, execution, and approval of all validation life cycle documentation such as VP,IQP,OQP,PQP,EPO’s.

Product transfer team validation lead.

ORVIS, Inc. – JANSSEN, GURABO (October 2004-October 2009) Application Systems Integrator/Project Manager

Design and implementation of automated processes for system management and maintenance and the implementation of monitoring tools such as SAP XMII, Manual Dispensing System, Maximo, and Mercury Quality Center (Test Director).

Managing application implementation projects of various scales from initial needs analysis through final deployment.

Extensive work in groupware application design and development and integration with external enterprise data sources.

Information technology planning, design and implementation services; systems integration and migration projects.

Mansiones del Caribe calle Topacio

AD-35 Box 343 Humacao, PR 00791

787-***-****-Mobil

Email: acr4xx@r.postjobfree.com

Successfully managed sign off, compliance, statements of work, project schedules, release processes and procedures for many systems integrators and projects including Accenture, IBM Global Services, and TCS.

Successfully ran many customer workshops and customer presentations to customers and external vendors.

Authored "systems integrations" documents such as Functional Specifications, Design Specifications and Interface Agreements on all projects completed as an independent consultant.

Experienced in interviewing and hiring outstanding project team members and contractors.

Experienced in project planning, project management and pre-production unit test and regression test plan generation.

Computer system validation support in the implementation of the electronic Process Execution System (ePES) for the Manufacturing, Packaging and Warehouse areas.

Responsible of conducting Computer System Validation activities for the information management area.

Lead the validation activities in the development and execution of qualification protocols for manufacturing equipment, utilities and facilities. Coordinate the activities of the contracted resources to achieve project goals efficiently on timely basis. Review and approved qualification protocols, engineering studies, commissioning reports, deviation report and summary reports for: Fluid Bed Dryers, Tablet Press Machines, Coating Machines, Solvent Distillation System, Compressed Air System and Computerized Systems among others

Provided support to department management in 21 CFR Part 11 project.

Worked in the review and update in the sites Business Continuity Plan (BCP).

Development and review of all CSV validation documentation including sites Master Computerized Systems Validation Plan.

General support activities for all Information Management Department activities.

Complaint and Manufacturing/Packaging/Environmental non-conformance investigations; including Corrective Actions, training and modifications to specifications and procedures.

Failure investigations, Complaints handling, materials review, corrective actions. Provide technical support to manufacturing areas, analyze production and material problems and troubleshoot manufacturing activities to improve processes, product quality and costs.

Develop, evaluate and optimized: designs, process specifications, and procedures, manufacturing operations, equipment, inspection parameters and drawings. Execute Product Transfers and required Validations, Validation Plans and schedules. CAPA/Deviations Investigator

Failure investigations, Complaints handling, materials review, corrective actions. Provide technical support to manufacturing and packaging areas, analyze production and material problems and troubleshoot manufacturing activities to improve processes, product quality and costs. Develop, evaluate and optimize: designs, process specifications, procedures, manufacturing operations, equipment, inspection parameters and drawings.

Development and execution of several FMEA.

COMPLIANCE & INTEGRATION SERVICES, INC. – MANATI, PR (MAY 2004-OCTOBER 2004) Manufacturing Technologist (MOVA Pharmaceuticals)

Responsible of conducting all Notice of Events Investigations related to the manufacturing department reporting directly to the QA Manager, leading to the release of several lots in hold.

Implementation of all investigation related CAPA’s (Corrective Action/Preventive Action).

Generating manufacturing batch records revision to improve the manufacturing process. Mansiones del Caribe calle Topacio

AD-35 Box 343 Humacao, PR 00791

787-***-****-Mobil

Email: acr4xx@r.postjobfree.com

COMPLIANCE & INTEGRATION SERVICES, INC. – MANATI, PR (JUNE 2002- MAY 2004) Project Manager (Pfizer Global Manufacturing)

Responsible for all validation activities to equipment/systems when needed computer validation.

Change Request generation, review and approval for all departments.

Audited and approved protocol development, execution and Final reports.

Contracted external resources for validation services.

Provided support on Process Control activities such as troubleshooting, manufacturing improvements, etc.

Responsible of developing Site’s Validation Master Plan.

Responsible for approving computer system validation assessments reports for equipment/systems to be waived from computer validation activities.

Project Manager for Electronic Records/Electronic Signatures implementation project.

Assessed all equipment/systems of the site (256 total ranging from Laboratory systems, manufacturing equipment, packaging equipment, Utilities, etc.) for 21 CFR Part 11 compliance.

Responsible of non-compliance system upgrades consisting of new equipment purchase, audit trail log development, personnel training, etc.

Developed several “Capital Project Appropriation” (CPA) managing funds up to 3M for investment on equipment for compliance in 21 CRFR Part11. All CPA’s were approved.

Team member of the corporate “US Area Drug Product ERES (Electronic Records/Electronic Signatures) Committee” reporting directly to the IT Director.

Provided quarterly meetings to inform project status and progress.

Responsible of notifying QA on any new guidance or position towards Part 11 maintaining constant monitoring on FDA releases.

Performed CIP (Cost Improvement Projects).

Computer Validation for Uhlmann Vision System, Compressor Machines (Korsch, Manesty). CARIBBEAN VALIDATION SERVICES, INC. -CAGUAS, PR (APRIL 2000- MAY 2002) SR. COMPUTER VALIDATION SPECIALIST

Ivax Pharmaceuticals- Cidra, PR

Responsible for the development and revision of IQ/OQ protocols and summary reports for equipment in the production area and packaging lines. Systems included the Killian Tablet Press, Manesty Layer Press, Fillers, and Unscramblers. Case Packers, Cartoners, Cappers, and labelers.

Pfizer Pharmaceutical- Vega Baja, PR

Responsible for the development and revision of IQ/OQ protocols and summary reports for equipment in the manufacturing area. Provided Part 11 assessment and remediation plans to equipment control system. Developed and executed computer validation protocols for encapsulation machines and vision systems. Exposes to Siemens and Allen Bradley SLC500, Omron and Micrologix PLC’s

Bristol-Myers Squibb- Barceloneta/Humacao, PR

Responsible for the development and revision of IQ/OQ protocols and summary reports for equipment in the manufacturing area. Developed and executed bulk manufacturing chemical process qualification with reactors, tanks, pumps, heat exchangers, horizontal and vertical centrifuges, dryers, filter dryers. Member of the C.I. (Continuous Improvement) team responsible of coordinating process improvement plans based on K.P.I. (Key Performance Indicators).

Pharmacia-Arecibo,PR

Responsible for the development and revision of IQ/OQ protocols and summary reports for equipment in the manufacturing area. Developed Validation Plans, User Requirements Mansiones del Caribe calle Topacio

AD-35 Box 343 Humacao, PR 00791

787-***-****-Mobil

Email: acr4xx@r.postjobfree.com

Specifications, Design Specifications.

Wyeth Pharmaceuticals- Guayama, PR

Responsible for the development and revision of IQ/OQ protocols and summary reports for facilities qualification. Developed and executed HVAC protocols and temperature mapping for laboratory and warehouse areas. Developed and executed qualification protocols for process equipment such as encapsulation machines (MG2 Models), compression machines, capsule polishers, capsule transfers. Developed Part 11 assessment worksheet to be used in all cGMP equipment.

Schering-Plough-Las Piedras, PR

Responsible for the complete validation life cycle of MG2 Encapsulation Machine. Developed and executed Factory Acceptance Test in Bologna, Italy. VALIDATION TECHNOLGY SERVICES, INC.- MASSACHUSETS (NOVEMBER 1999- APRIL 2000) VALIDATION SPECIALIST

Validation Specialist for validation projects in pharmaceutical industries.

Schering-Plough- Manati, PR

Responsible for the development and revision of IQ/OQ protocols and summary reports for packaging area and chemical plant. Assigned 42 equipment and systems for validation were 35 were successfully completed.

EDUCATION

BS in Electrical Engineering

Turabo University, Gurabo, PR

American Society of Quality (ASQ)

Certified Quality Engineer Academia Course

Project Management Institute of PR (PMI)

Project Management Course Certification

QUALIFICATIONS AND SKILLS

Computer knowledge of the following software: Windows MS: 98, 2000 and NT, MS Office, Programming Language (C Electronic Simulation, MS Project.

SCADA systems, PLC I/O simulation, Source Code programming verification.

Excellent written and oral communication skills in English and Spanish.

Strong Leadership, Teamwork Abilities and Public Relations.

Knowledge of GMP’s, OSHA and FDA Regulations.

DataStream ( Application which covers Purchase Orders, Requisitions, Work Orders, Service Entries, Calibration), CALMAN, DOCUMENTUM

One Source application Johnson & Johnson document database tool.

Test Director 8.0 application to execute software validation.

Statistical Process Control and Process Capabilities Analysis

QUMAS document management application

Mansiones del Caribe calle Topacio

AD-35 Box 343 Humacao, PR 00791

787-***-****-Mobil

Email: acr4xx@r.postjobfree.com

TRAININGS AND SEMINARS

Fundamentals and Advanced Programming using PLC 5/SLC 500 (RS Logix 5/500)

Introduction to CSV / GxP / SLC

Writing a Validation Plan / System Requirements Specifications and Designing and Performing a Risk Analysis. Writing a System Design Specification / and IQ/OQ/PQ

Executing Validation Test Protocols / Writing a System Retirement Plan and Creating a System Management Plan.

Advance Course on 21 CFR § 11-Electronic Records and Electronics Signatures.

Compliance and Remediation for 21 CFR §11, Validation of Computer System for 21 CFR § 11.

cGMP Qualification for Automated Process Control System

Current Good Manufacturing Practices. Safety and OSHA Regulations.

Certified Quality Engineer course by ASQ PR chapter. Society’s

ASQ (American Society for Quality)

IEEE (Institute of Electrical and Electronic Engineers) ISP (International Society for Pharmaceutical Engineering) PMI (Project Management Institute)

References

Will be submitted upon request.

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