F. Xavier Arcentales                                                                         

Project Mgr/Sr. Quality Engineer

Engineering and Validation Management professional with extensive experience supporting the pharmaceutical and diagnostics industry (cGMPs, CFRs, FDA Guidelines).   Expertise in the following areas: Project Management, Validation Management, Process Transfer and Development, New Product and Process Design, Process Validation, Packaging Engineering, Primary and Secondary Packaging Automation, Capacity Analysis and Planning, Cost Reduction.

EXPERIENCE…

• Member of a new product development team with responsibility to set-up all manufacturing operations including process specifications, equipment selection, evaluation, purchasing, installation, validation, facilities design and qualification, training, and documentation.
• Major contributor in the design, development and evaluation of all process requirements and equipment: e.g.: micro dispensing, laser drilling, drying, Ultrasonic welding, etc.
• Finalized development of the Test Method Validation procedure for a major device manufacturer.
• Supported the implementation of a multi-site CAPA system.
• Completed qualifications of Facilities and Utilities of controlled environments used for balloon manufacturing. Developed and optimized process parameters specifications for Injection Molding and a semi-automated Ultrasonic Welding assembly process by utilizing DOE methodologies and MINITAB software applications.
• Responsible for $14MM reagent technology transfer from Miami to Puerto Rico including training, documentation, engineering of processes and facilities, capacities, equipment installation and validation.
• Responsible for managing the commissioning and validation of a new 250,000 sq. ft. OSD pharmaceutical facility including Utilities (Nitrogen, Compressed air, Steam, HVAC), Class 100,000 Facilities, and various process equipment for the preparation of OSD.
• Responsible for validation of facilities (Class 100), utilities (USP Water, Clean Steam, C/A), process equipment (Bulk, Filling, Packaging), Computer Systems, Sterilization (EtO, Gamma, Steam, Dry Heat) for pharmaceutical manufacturing facility.
• Implemented project management systems to organize validation projects. Designed and implemented a document control system for all validation activities.
• Managed the transfer of a domestic high-speed line to a facility in Europe.   The line included a Filler, Capper, Labeler, and Automated Packaging machines.
• Provided engineering support (Project, Process, Packaging, and Industrial) for facilities in Puerto Rico.
• Identified and implemented cost savings in excess of $420K per year by automating a highly manual packaging process.
• Implemented $2MM annual savings obtained from packaging improvements and labor cost reductions.
• Implemented savings of $200K/yr. in refrigerated warehousing costs as a result improvements in layouts and material handling methods.

POSITIONS HELD…

• Project Mgr/Sr. Quality Engineer                          BioTeknica
• Validation Manager                                               Bausch & Lomb Pharmaceuticals, Inc.
• Manufacturing Engineering Manager                   Dade Behring
• Project Engineer                                                   Baxter Diagnostics
• Manufacturing Engineer                                       Baxter Diagnostics
• Associate Engineer                                               American Hospital Supply Corporation

EDUCATION…          

• Bachelor of Science, School of Engineering & Applied Science              Columbia University, N.Y.