Milton Collazo                                                                                                                      

Sr. Quality Engineer

Milton has over fifteen years of diversified project engineering, validation project management, quality auditing and maintenance management experience within the pharmaceutical and medical device industries.  Practical knowledge and experience of FDA Quality Systems Regulations, cGMP’s, 21 CFR Part 11 and the ISO quality systems standards.  Results oriented professional, particularly effective in validation project management, remediation compliance and documentation.  Demonstrated expertise in developing and conducting equipment qualifications (IQ, OQ and PQ), process validations, development and implementation of validation master plans, Gap Analysis, Process Assessments and leadership.  Technical expertise in sterile bulk compounding and filling processes, solid dosage manufacturing, sterilization of pressure vessels (autoclaves and mixing tanks), pharmaceutical water systems, process utilities (HVAC, gases, chilled water, clean air and clean steam systems), process capability, automatic measurement and computer control systems.

EXPERIENCE…

• Developed Site Validation Master Plan and developed SOP’s for the Validation Program for a pharmaceutical manufacturing company
• Developed Gap Analysis Reports for Calibration and Preventive Maintenance Systems and provided regulatory and compliance guidance during site audit.
• Developed manufacturing and packaging equipment process validation gap assessments for a pharmaceutical manufacturing company.
• Developed and executed IQ, OQ and PQ’s for custom built manufacturing equipment used in the manufacture of diagnostic pregnancy tests
• Developed and executed of IQ and OQ’s for laboratory equipment including centrifuges and spectrophotometers.
• Developed Validation Master Plan and performed equipment qualifications for a wet micro-fiber extrusion process for hollow fiber products used for ultra-filtration of blood compounds during peripheral dialysis.
• Performed re-validation of an autoclave cycle, PQ for bulk compounding of an ophthalmic steroid, validation of a Form, Fill, Seal machine used for lubricant eye drops, and validation of SIP and in-situ sterilizations.
• Developed and executed IQs and OQs for Clean-In-Place (CIP) equipment used for the manufacture of solid dosage bulk material.
• Developed and executed cleaning validations for pharmaceutical company including Maximum Allowable Residual analysis and Detection Limit determination.
• IQ, OQ and PQ development and execution for energy management and temperature monitoring systems, purified water systems, freezers, compressors, HVAC systems, dust collector systems, and controlled environmental  rooms.
• Performed validation of production equipment including tablet coating machines, rotary tablet press, encapsulators, capsule weigh check machines, and automated packaging lines.

POSITIONS HELD…

• Sr. Engineer                                                                      BioTeknica
• Principal Engineer                                                             Collazo Engineering                                              
• Design Engineer / Assembly Shop Supervisor                Material Handling Systems Inc.
• Maintenance Supervisor                                                  The All American Gourmet – Div. Of Kraft Food
• Process Engineer and Maintenance Supervisor              E.I.DuPont Diagnostics

EDUCATION…

• B. S.  in Mechanical Engineering                                      University of Puerto Rico – Mayagüez Campus   

TRAINING…