Jorge Rodriguez

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Principal/Project Manager

Jorge is a co-founder of BioTeknica.  He has more than twenty years of experience in the pharmaceutical, medical device and diagnostics industry with experience in project management, hands-on validation of both medical device and pharmaceutical processes including computer systems validation.  Jorge has led large scale remediation projects across multiple sites including all facets of project from assessments, planning, deployment and implementation which have resulted in successful FDA Inspections.

EXPERIENCE…
  • Principal, BioTeknica, Inc.
  • Project Manager overseeing 15 consultants and interfacing with site, division and corporate management in two-year remediation project across multiple quality systems including P&PC, CAPA, Environmental Controls, Purchasing Controls and Complaints for an implantable device manufacturer.
  • Project Manager for Validation Remediation Project resulting from a corporate warning letter for multinational diabetes test strip manufacturer.  Project included developing validation strategies, coordination between consulting teams at overseas locations, gap assessments of existing validation packages and remediation.  Outcome was a successful FDA inspection at all three manufacturing sites with zero observations around Process Validation.
  • Project Manager for large consulting project with 50+ consultants for Class II and Class III Medical Device Manufacturer to revalidate all process (IQ/OQ/PQ/PPQ) and Test Methods (VTMV and ATMV) across more than 30 product lines.
  • Project Manager for Class II and Class III Medical Device Manufacturer to train multi-site teams on validation.  Items included Injection Molding, Welding, Bonding, Form-Fill-Seal.
  • Site Manager of project to revalidate all facilities, utilities, equipment, computer systems, and processes for a leading Pharmaceutical manufacturer in consent decree.  Project completed on time and within budget.
  • Performed validation of complex packaging machinery with integrates vision systems (ampule filling, robotic pick/place packaging, high speed cap/label, high speed filling w/ robotic check-weighing) including protocol development, execution and final report.
  • Identified and implemented packaging process improvements that led to over $1.0 Million in annual savings for a leading Pharmaceuticals manufacturer.
  • Performed validation of several building automation systems (software and hardware) that monitor and controls environmental conditions for a various classifications of cleanrooms for Class III medical device mfg facilities.
  • Validation of various Vision Systems including Cognex and Keyence used to detect defect types across various products including syringe packaging operation, test strips, and labeling.
  • Overall Validation QA responsibility including Master Validation Plan development and execution, Protocol Approvals, Final Report Approvals for a leading multinational IVD manufacturer.
  • Overall responsibility for all technical aspects of hematology instrument manufacturing process for three product lines in the focused factory.
  • Conducted process validation of final test process for hematology analysis systems.
  • Participated in “Blitz” Team that reduced manufacturing related discards and customer complaints by 50% for a leading medical device manufacturer by implementing process improvements in extrusion, component fabrication, and finishing areas.
  • Managed $2MM budget and member of project team to consolidate 220K sq. ft. R&D facility including all supporting equipment (i.e. hoods, washers, sterilizers, tablet presses, fluid bed granulator, refrigerators/freezers, etc.) and utilities (compressed air, vacuum, purified water, electrical, steam).
  • Overall project responsibility for the transfer from US to Switzerland of a CBER licensed, Immunohematology product line.
  • Managed day-to day operations of bulking, filling, quality control, and materials planning groups for respiratory care (blood gas controls) product line.
  • Developed storage capacity plans for WIP and finished goods inventories determining impact on overall plant refrigeration storage capacity.
POSITIONS HELD…
  • Principal/Project Manager – BioTeknica, Inc.
  • Senior Manufacturing Engineer II – Beckman Coulter Corporation     
  • Senior Staff Engineer – Dade International Inc.    
  • Staff Engineer – Baxter Diagnostics Inc.
  • Associate Engineer – Baxter Diagnostics Inc.
EDUCATION…
  • B.S., Industrial and Systems Engineering – Florida International University
CONTINUING EDUCATION…
  • Just-In-Time (JIT) Manufacturing Philosophy
  • Design, Operation, and Validation of Steam Sterilization Systems Seminar
  • Contamination Control in Clean Rooms
  • Statistical Process Control (SPC) – Six Sigma Quality
  • HACCP – Hazard Analysis and Critical Control Points