Senior Validation Engineer / Project Leader, Solid and Semi-Solids Dosage Facility, Wyeth Pharmaceuticals, Guayama, Puerto Rico
New USP Purified Water System - Generated the New USP Purified Water System Master Validation Plan. Developed the IQ/OQ/PQ Protocols for the Pre-treatment system, Distillation tanks, storage tanks and Distribution loops of the New USP Purified Water System. Coordinated the validation activities, including project management. Coached assigned validation specialist resources.
Senior Validation Engineer / Project Leader, Bio-Parenteral Facility, Ortho Biologics, Manati, Puerto Rico
Compressed Air System Expansion - Generated the Compressed Air Master Validation Plan. Involved in the Part 11 assessment. Developed the project strategy. Coordinated the validation activities, including project management. Coached assigned validation specialist resources.
Senior Validation Engineer / Project Leader, Medical Devices Facility, Guidant, Dorado, Puerto Rico
Facilities Qualification - Coordinated the validation activities, including project management. Coached assigned validation specialist resources.
Validation Certification Program- Control Support System Group, Parenteral, Semi Solids, API and Aerosols Facility, Schering Products, Manatí, Puerto Rico
Reviewed the manufacturing support systems that fall within the scope of the Consent Decree of Permanent Injunction, to ensure that the appropriate controls are in place and there is support data confirming expected system performance. The review process included assurance that the critical facility systems that support the process area (such as water, HVAC, etc.) were adequately controlled as demonstrated through qualification, the use of appropriate interim control and supporting data.
Senior Validation Engineer, MP2 (Preventive Maintenance Program) IOPQ, Schering Products, Manatí, Puerto Rico
Assigned to coordinate the validation activities. Wrote System Development Life Cycle Documentation and executed the System Qualification (IQ / OQ / PQ) Protocols and Reports. Documents involved : User and Functional Requirement Specification, System Design and Functional Specifications, Computerized System Validation Plan, Traceability Matrix, Installation / Operational / Performance Qualification Protocols, Standard Operating Procedures (Operation, Data Back Up and Disaster Recovery, System Security).
Senior Validation Engineer, Solid and Semi-Solids Dosage Facility, Ortho Pharmaceuticals, Manati, Puerto Rico
Involved in the generation of the Computer System Validation (CSV) documentation for the 2 gr Line IWKA TU-200 semi-solid Filler. Major responsibilities included Development of System Development Life Cycle Documentation and execution of the Equipment Qualification (IQ / OQ / PQ) Protocols and Reports. Documents involved: User and Functional Requirement Specification, Gap Analysis, System Design and Functional Specifications, Computerized System Validation Plan, Traceability Matrix, Installation / Operational / Performance Qualification Protocols, Standard Operating Procedures (Data Back Up and Disaster Recovery, System Security). Equipment, Systems, and Process involved : IWKA TU-200 semi-solid Filler.
Senior Validation Engineer, Solid and Semi-Solids Dosage Facility, Ortho Pharmaceuticals, Manati, Puerto Rico
Involved in the generation of the Computer System Validation (CSV) documentation for new FETTE tablet press model P2200 to replace the existing oral contraceptive placebo tablet press. Major responsibilities included Development of System Development Life Cycle Documentation and execution of the Equipment Qualification (IQ/OQ/PQ) Protocols and Reports. Assigned to coordinate the validation activities, administrate Project Management and Budget Control of project. Documents involved: User and Functional Requirement Specification, System Design and Functional Specifications, Computerized System Validation Plan, Traceability Matrix, Installation / Operational / Performance Qualification Protocols, Standard Operating Procedures (Operation and Cleaning, Data Back Up and Disaster Recovery, System Security). Equipment, Systems, and Process involved: FETTE Tablet Press Model P2200. Executed the IQ, OQ, PQ Protocols for the Schleuniger AT 4 Systems with Software CSV.
Design Engineer, Solid Dosage Facility, Pharmacia, Upjohn, Arecibo, Puerto Rico
Involved as a validation engineer in the validation and start-up activities of the new Dry Product Facilities (DPF). Major responsibilities were to coordinate the validation activities, to generate and execute the equipment and utilities qualification (IQ / OQ / PQ) protocols and reports. Installation / Operational / Performance Qualification Protocols. Was responsible for the preparation of Final Summary Reports and Validation Packages. Atlas Copco air compressor systems and air dryers. AHU of the process and facilities.
Validation Engineer, Solid and API Dosage Facility, Merck Sharp & Dohme, Barceloneta, Puerto Rico
Involved in the generation of the IQ modules for the new API building facilities. These IQ modules were generated from the pipe and instrumentation diagrams (P&ID’s) designed for the new equipment and utilities installed at this building. Major responsibilities included: Preparation of Utilities and Equipment Qualification (IQ) Protocols, and Reports. Coordination of qualification activities with the construction team in order to verify the installations of all equipment, piping, instruments, calibration and maintenance for the GMP and Non-GMP facilities and utilities. Implementation of training course for new recruits in the Merck’s standards and documentation processes.
Validation Engineer, Solid and API Dosage Facility, Merck Sharp & Dohme, Barceloneta, Puerto Rico
Involved in the Year 2000 compliance assessment and computer validation of the Factory three (3) building. Verified if the inventory meets with the Y2K requirements and complete Inventory Closure forms. Assigned to administrate the project time. Major responsibilities included: Preparation and Execution of Utilities and Equipment Qualification (IQ/OQ) Protocols, and Reports. Installation/Operational Qualification Protocols and Reports and Standard Operating Procedures. NIR Systems Spectrometer and PanelMater® Plus control panel. Coordination and supervision of the installation of Yokogagua digital chart recorders.
Senior Validation Engineer / Project Leader, Solid Dosage Facility, Janssen Ortho LLC, Gurabo, Puerto Rico
J1 and J2 Compressed Air Consolidation Project - Assigned to coordinate the validation activities, including project management. Development of the Master Validation Plan. Was responsible for the coordination of the Process Validation for the Metalchek metal detector used for the inspection of capsules products. This included: preparation, execution and report generation of the Performance Qualification (PQ) and equipment set-up according to the cGMP’s and Janssen procedures guidelines. Involved as a validation engineer in the Presidents Corrective Action Plan (PCAP) project to perform the installation and operational qualification (IQ/OQ) of various equipment’s installed at the manufacturing plant area. Assigned to coordinate the validation activities, to generate and execute the Equipment Qualification (IQ/OQ) Protocols and Reports. Installation/Operational Qualification Protocols, Responsible for the preparation of Final Summary Reports and Validation Packages, Standard Operating Procedures for the following equipment: Manesty Express Compressing Machine, Broken Bag Detector for the Glatt #1, Metalchek metal detector, Manesty Rotapress, MK IV Compressing Machine, Collete Planetary Mixer, Patterson-Kelley (PK) Blender 20 cu-ft, LB Bohle Bin Blender, Drum/Bin lifter and/or Inverters (Metolift, Glatt, LB Bohle), Fette PT 3090 Tablet Press.
Bio-Parenteral Facility, OMJ Pharmaceuticals, Inc., San German, Puerto Rico
Year 2000 Compliance Assessment and computer validation. Was responsible for the preparation, execution and report generation of test procedures to verify the Year 2000 compliance of all devices with date-base functions. These test procedures challenged the equipment capability to rollover to the year 2000 and output the year correctly.
