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Robert Castater                                                                               

Project Mgr/Sr. Quality Engineer

Bob is a Licensed Professional Engineer with diversified managerial and hands-on experience in the Medical Device, Pharmaceutical, and Clinical Diagnostic industries. Bob is a former Manager of Engineering with a solid track record in project management, validation, quality systems, and equipment design.   Experience includes a broad background in manufacturing technologies, organizational development, and business processes.

EXPERIENCE ...

• Member of 3 rd party consulting team responsible for successfully resolving Production Process Control issues for diagnostics manufacturer under consent decree.
• Quality Systems Consultant for OEM manufacturer of medical device components. Performed Gap Analysis and assisted in developing systems (procedures, calibration, preventive maintenance, change control, validation, training) to support cGMPs.
• Responsible for product process validation at medical diagnostics company to clear FDA warning letter.   Used statistical tools such as Analysis of Variance and Design of Experiments.  
• New product design work ranging from original component design to setting final product incoming specifications with setup of Statistical Process Control for monitoring during manufacturing.
• Substantial device validation experience, including new product design, process, and test methods validation.  
• Led multi-disciplinary team charged with developing a Validation Master Plan and establishing a validation program for a multi-plant division.   System was designed to be in compliance with ISO-9000, cGMP’s and proposed QSR’s.  
• Conducted both original raw material sourcing (search and plant inspection) and supplier audits to insure incoming components and raw materials met specifications
• Led engineering effort on various medical device new project development teams  
• Conducted both original raw material sourcing (search and plant inspection) and supplier audits to insure incoming components and raw materials met specifications
• Designed, built, and validated low oxygen filling equipment for use in an Aseptic Environment.  
• Project Manager for Stratus Puerto Rican Plant expansion designed for manufacture of immunochemistry reagent system.   This multi departmental project including new facilities, custom designed equipment and product transfer.
• Project Manager for Paramax Reagent Team charged with implementing new multi-plant manufacturing and Quality Control Processes for a new reagent/instrument system.
• Managed product transfer team that transferred products from non-domestic business partners to domestic facilities.
• Led software development team that developed and implemented improved operating process.
• Led an Immunochemistry Process Development Team for new multi-component reagent instrument system.
• Responsible for capital projects for multi-plant diagnostics manufacturing.   Primary, processes were protein purification, filling and lyophilization.   Operating conditions ranged from open to sterile manufacturing.
• Managed cost improvement projects resulting in an average savings of $ 3 million annually for diagnostic bulk processing operations in the U.S. and Puerto Rico.
• Revised human protein processing to reduce waste and eliminate processing time.
• Designed and built components, production system and facility for blood collection Devices. Designed new large volume parenteral containers, using a combination of injection molding, blow molding, dialectic sealing, heat sealing and other methods.  

POSITIONS HELD...

• Project Mgr/Sr. Quality Engineer                   BioTeknica
• Manager of Engineering                                Baxter Diagnostics
• Manager, Product Engineering                      NABI
• Project Engineer                                           McGaw Laboratories

EDUCATION...

• Masters in Business Administration              Florida International University
• B.S. Chemical Engineering                            NorthWestern University