Senior Validation Engineer

• Aug 2022 - Present

Site Lead Quality Assurance & Control Engineer

• Mar 2021 - Jun 2022

Fulfill all Quality Assurance requirements for new start-up Medical Device life sciences company. Assist in development of QMS, for high level Company scale down to site specific. Review & approve planned and performed works as QA. * Function as SME for several Quality and Regulatory tasks demanded to be fulfilled by Medical Device manufactures; Quality Control, Quality Assurance, Validations, Design Control, Change Control, Training, and Metrology. * Collaborate with executives and managers in creation of Risk Management, Design Control, Change Control systems and oversight requirements. * Draft SOPs needsd to fullfill FDA cGMP (cGxP) and ISO 13485 requirements. * Assist with potential Plant layout and Engineering issues for new manufacturing facility. * Support Validation engineers in the creation of Validation Plans/protocols, execution, final approval of newly designed and built manufacturing equipment, Analytical Instruments and Processes. * Devise Test Protocols for verification of product specs, equipment specs, and user requirement specs; ensuring each specification is met and maintained throughout Qualification and manufacturing. * Serve as Laboratory specialist for development of QC Laboratories to be built at new manufacturing facility, including utilities and equipment required. * Help to develop and validate Test Methods for raw material inspection, in process checks and final product testing. * Implement and Oversee Calibration/Metrology program including: purchasing of correct tools and equipment, identifying calibration vendors for each type of tools/equipment, devising asset identification and tracking systems, drafting SOPs and PMs, providing training on proper handling, storage and use of calibrated tools and equipment. * Create Material Specification and Inspection requierment sheets for Raw Materials and Components. * Help in the development and execution of BPRs * Create, Review and Approve quality records. Show less

Senior Validation Engineer

• Mar 2019 - Dec 2020

Steward over design and implemention of Validation/Qualification programs. Responsible for bringing standards and compliance up to date to new TGA Process Validation (PV) requirements for Nutraceutical manufacturing * Project Development & Management * Manufacturing Process Engineering * Developed comprehensive Qualification, Validation and QC compliance programs * Bring GMP current to TGA and FDA regulatory requirements * Project Management includes: performing gap analyses & audits; Created new Validation Program and all related documentation including SOPs, PMs, site Validation Master Plan (VMP) and change control; product sampling & test plans; plant training * Identifed Quality Management System (QMS), Risk Management (QRM), GMP, GDP & GLP compliance gaps while providing feasible solutions * Assisted in new product development from start to launch. Introduced "Quality by design"(QbD) approach along with practical implementation * Engineered PVs (Process Performance Qualifications PPQs) for new and existing product processes * Introduced Software Validation (SV), creating site wide Software Requierment Specifications (SRS) & SV SOPs * Equipment Design Qualifications (IQ/OQ/PQ) on new and existing equipment * Label approvals, comparing against Customer Specifications and ARTG submissions * Review BPRs, investigating discrepencies and/or deviations. Ensured proper compliance to in-house procedures, TGA & FDA regulatory requirements * Completed NCRs, OOS investigations and CAPAs for products requiering full PV * Assessed Test Methods (TMs) and TM validations. Revised with current techniques, cutting test turnaround. Unified ATMV (Analytical TM Validation) practices * Devised a more effective & efficient PM Program, simplifying traceability * Metrology Project: Cut maintanance costs, increased capabilities and boosted reliability (accuracy & precision) of critical measuring devices through development of an in house Metrology Program Show less

Analytical Chemist & Validation Engineer, Polymer Plant/Laboratories

• Mar 2007 - Mar 2019

SCOPE: Assist in New Polymer plant development. Develop new physical and analytical Test Methods (TMs), SOPs, and Validations for the testing of polymers, raw materials and products. Assist in Plant and Laboratory Engineering, including identification and maintenance of all Test/Measurement tools, equipment and instruments requiered. * Review and evaluate current TM's for improvements in testing efficiency while maintaining and improving quality. * Ensure all TM Validations (PTMV/ATMV) compliance with FDA, ISO and other related industry standards and guidelines. * Stay up to date on changes to such standards and the requirements for Medical Device Manufacturing, testing and release. * Documentation Originator for department, over all change control (CC) projects and requests.* Experienced in use of many QMS software systems; Windchill PLM, SAP, LIMS and Blue Mountain Asset tracking (metrology).* Responsible for upholding site quality initiatives, assurance and compliance objectives in the development of TMs, SOPs, WIs, Validations, Polymer projects and implementation within the department. * Occasionally needed to provide assistance in performing disciplined problem solving for supplier, customer, and internal quality defects. * Perform QC and QA activities through OOS investigations, completion of NCRs and/or CAPAs .* Maintain knowledge of polymer related products, processes, and basic quality principles required to assist with daily operations and continual improvement activities. * Understand the technical aspects of PSF manufacturing; including raw material supplier products/processes, residual, derivative, and side reaction compounds; to drive quality improvements and communicate them clearly.* Maintain Laboratory Equipment and Verifucation tools/instruments. Ensure proper use within Manufacturer specs and Validated state, calibration, service, and overall quality function. See Attached Resume for Detailed Experience Show less

Sr. Polymer Lab

• Mar 2011 - Apr 2013

•Participated in Polymer Plant design, qualification; Quality, Design and Risk Review meetings. Communication skills needed to execute tasks with different departments and CFT collaboration.•Researched and created tests and studies for possible bio-compatible co-block polymers.•Developed and executed TM’s, SOP’s and Validations for analytical equipment including: GPC, HPLC, ICP, TGA, DSC, Phenolic Endgroup Titrations, Chlorine Analyzer, Accelerated acid Digesters, Density meters, Viscometers, FTIR and Titrations. Emphasis in Polymers and incoming materials.•Performed IQ’s, OQ’s and PQ’s on all the above instruments.•Researched FDA guidelines to write / execute Validation Plans / Procedures as well as implemented an organized and consistent template. Understand and implemented Quality and FDA guidelines/requirements for the development of Medical Device testing procedures•Wrote and executed VP’s for TM’s developed on GPC, Density Meter, ICP, GC, HPLC and TGA for polymer testing and characterization. •Received advanced training on method development and maintenance on all the above instruments.•Very comfortable using several different types of analytical software and maintain good working trustworthy relationships with service engineers.•Executed polymer synthesis experiments using chemical lab scale reactors. Assisted with bringing synthesis and reactor setup up to production scale.•Provided training to lab and polymer plant maintenance techs for specific analytical tests.•Maintained all data properly in Laboratory notebook, provided updates via excel and power point presentations. Show less

R&D Biotechnologies Lab Tech and Sr. Lab Tech

• Mar 2007 - Mar 2011

•Develop new test methods and standard operating procedures for Hemodialyzer in vitro synthesis and testing.•Research new technologies for incorporation into Hemodialysis therapies for renal disease.•Specialize in the Biotechnologies lab working with Bacterial DNA, blood, cultures, microbiology and chemistry techniques.•Surface analysis as well as wet chemistry, analytical techniques, data entry and analysis with Excel and Word Programs.•Maintain laboratory notebook, lab supplies, laboratory organization and inventory.•Present scientific information and project results in Power Point presentations to groups and management. Assist with research on published journal articles relating to the interactions of our Polysulfone membranes and the Hemodialysis circuit on the activation of the Blood Coagulation cascade.•Recently finished verification on bringing old test methods up to date with AAMI standards. •Worked on dialyzer coatings, such as Chitosan, Alginate polysaccharide Polymers as well as other additives to membranes for drug reduction therapies and Biocompatibility studies.•Work alongside with the Pilot Line on our “Oyster” project in the creating of modified fibers with spinmass additives.•Perform Surface analysis tests by Microscope, Contact angle and SEM. •Perform other regulatory tests such as Bubble Point, Ultra Filtration, Clearance (Sodium, Phosphate, Albumin, B2M), Blood Simulations, Housing integrity, ELISA, Fibrinogen/ Aptt Tests, Hemolysis, Protein and DNA Gel Electrophoresis, Endotoxin Transfer studies and fluorescence simulations, and Calcium trapping. Show less