Steve Maltz                                                                                                   

Sr. Operations Consultant                             

Steve has diversified operations experience in pharmaceutical, medical diagnostics, and device manufacturing. Background blends a strong technical orientation with results-oriented business skills in production, engineering, and regulatory compliance. Strong focus on quality, efficiency, and team empowerment with proven track record in process improvement, validation, aseptic processing and quality control.

EXPERIENCE...                     

• Developed and directed engineering team responsible for analysis, process modifications, and validation of equipment and processes utilized at a medical device manufacturing company.
• Performed assessments of validation systems, protocols and final reports for numerous pharmaceutical and medical device companies.
• Developed and implemented environmental programs for several medical device and diagnostic manufacturing operations.
• Completed replacement/retrofit of equipment, utilities, and facilities used for environmentally controlled manufacturing operation.   Responsible for managing fabrication/construction/ installation as well as developing enhanced procedures and performance of validation.
• Developed process blue print of multi-site business operation utilized for design of an enhanced facility.   The process and facility design modifications provided a $1.2 million annual return thru improved efficiency, reduced cycle time, reduced space, and elimination of non-value added activities.
• Implemented modifications, developed procedures, trained personnel, implemented teams, and retrofitted several production lines for diagnostic and medical device companies.
• Performed hands-on validation of equipment and utilities for several pharmaceutical and medical device companies.
• Managed contract engineering team responsible for validation of a new pilot manufacturing facility and equipment to be utilized for an implantable solid dosage drug.
• Increased product yields in aseptic production by 20% through facility modifications, procedural enhancements and personnel training.
• Implemented numerous process improvements resulting in reduced scrap, increased yields, and reduced production cycles.

POSITIONS HELD...

• Sr. Operations Consultant                                    BioTeknica
• Manufacturing Director                                         Telectronics Pacing Systems
• Operations Consultant                                          Telectronics Pacing Systems
• Manufacturing Manager                                        Baxter Diagnostic, Inc.
• Manufacturing Superintendent                              American Hospital Supply Corp.
• Aseptic Production Supervisor                             American Hospital Supply Corp.
• Research Technician                                             University Miami MedicalSchool

 EDUCATION...

• B.S. Life Science                                                    New York Institute of Technology

CONTINUING EDUCATION...

Process Validation                                                     Calibration
GMP Auditing                                                              ISO 9000
TQM                                                                            CF M
Cleaning Validation