Experience

Cauldron Ferm

• Australia
• Manufacturing
• 1 - 100 Employee

• Research And Development Manager

  • Mar 2023 - Present



Agritechnology Pty Ltd

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Research And Development Manager

  • Nov 2022 - Apr 2023



Virbac

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer

  • Apr 2022 - Oct 2022



Bioproperties Pty Ltd

• Validation Engineer

  • Sep 2020 - Apr 2022

• Eimeria EU Validation Manager

  • Sep 2019 - Sep 2020

• Eimeria Product Manager

  • Mar 2018 - Apr 2020

• Assistant Product Manager

  • Apr 2017 - Mar 2018

• Validation Scientist

  • Nov 2011 - Apr 2017

  Plan and manage all aspects of validation and development projects including preparation of protocols, co-coordinating and conducting validation work, supervision and training of staff, execution of bench work as required, preparation of reports and final implementation into laboratory / productionRegulatory Compliance – Ensuring that all procedures and systems applicable to Validation and Development work are compliant with the relevant regulatory authorities and cGMP. TGA, APVMA, and EMA. Writing and updating existing documents and procedures, and process implementationProcess Validations - New and existing processes (development, writing and execution of protocols, implementation of validated processing methods, and associated training)Development of freeze drying programs for novel productsAssisting with product development to commercial scaleBacterial, viral and coccodial productsTraining of Production personnel in aspects of microbiology and sterility ensuring adherence to cGMP and correct performance of processes.Equipment Validations – Performance qualifications (Writing and/or execution of IQ/OQ/PQ for current and new equipment)Media fillsTest Method Validations – New and existing test methods (development, writing and execution of protocols, implementation of validated test methods, and associated training).Assist with R & D Bacterial, Viral, Coccidial projectsLiaise with multidisciplinary teams on ongoing projectsProduction Team SupportChange Controls (CC) and CAPA Show less

• Validation Engineer

  • Nov 2011 - Apr 2017



Virbac

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Projects Leader

  • Nov 2009 - Oct 2011

  Projects aimed at improving compliance in the laboratory and improving technical performance of methods used within the laboratory. Plan and manage all aspects of projects including preparation of protocols, training of staff, execution of bench work as required, preparation of final reports and final implementation into laboratory. Regulatory Compliance – Ensuring that all procedures and systems applicable to Sterility, Microbiology and general laboratory areas are 100% current. Regulatory Authorities include the TGA, FDA (USP), and EMA (EP). Writing new and updating existing documents and procedures, and implementation of aforementioned documents. QC Analyst Training – Training of QC Analysts in Microbiology and Sterility ensuring adherence to GLP and correct performing of tests. Equipment Validations – Writing and/or execution of IQ/OQ/PQ for current and new equipment. Test Method Validations – New and existing test methods (development, writing and execution of protocols, implementation of validated test methods). QC Team Support Provide a technical resource for QC staff to assist with trouble-shooting, method performance and investigations. Test deviation investigation assistance. Mentor QC staff at the bench level to improve technical skills and increase understanding and adherence to GLP. Immunology testing backup. Laboratory Management Support Show less



Bodene Pty Ltd

• Port Elizabeth Area, South Africa

• Microbiologist, Senior Microbiologist

  • Nov 2006 - Sep 2009

  Supervision of laboratory assistants (Environmental and Water) & Junior Microbiologists. Preparation and pouring of media/buffers and reagents. Reading, interpretation and documentation of all environmental sample results, water and product total viable counts. OOS investigation, documentation and resolution. Sterility testing. Trending databases for Water and Environmental results. Bioassay preparation and testing (Heparin potency determination using the APTT coagulation test and agar diffusion assay). Heat Lethality Testing on LVP and isolated sterility positive organisms. Initiate and compile any validation protocols needed, together with the required testing, interpretation and documentation for all microbiological testing procedures. Stability testing Administrative duties, i.e. test results, special requests, procedural updates, archiving, checking co-microbiologist documented calculations, procedure compliance, compiling reports and completing OOS investigations. Following and practicing GLP and Housekeeping by ensuring samples are submitted for growth promotion, destruction of live micro-organism cultures, maintenance of Primary cultures and Reference standards, etc. Ensuring correct use, maintenance and calibration of laboratory equipment . Assisting laboratory assistants with sterility testing, environmental and water sampling and testing when necessary. Assisting Production and Endotoxin Microbiologists with OOS audits, investigating and compiling OOS audits, micro-organism identifications, processing throat swabs and testing of disinfectants. Active participation of micro related projects which are aimed at reducing OOS results both in the laboratory and production areas. Training of laboratory and production staff with respect to departmental procedures and other microbiological topics. Promotion of GLP and GMP within Microbiological Laboratory. LAL Bacterial Endotoxin test & Gel clot bacterial endotoxin test. Show less



Woodlands Dairy

• South Africa
• Dairy Product Manufacturing
• 200 - 300 Employee

• Trainee cheesemaker and factory floor supervisor

  • Apr 2004 - Jan 2006

  Commercial cheddar and gouda cheese production, small batch processed cheese and feta production. Shift work, factory floor supervisor. Commercial cheddar and gouda cheese production, small batch processed cheese and feta production. Shift work, factory floor supervisor.



Ostriland

• Western Cape, South Africa

• Dyehouse colormatcher

  • Jul 2003 - Feb 2004

  Ostrich leather color match and dying. Ostrich leather color match and dying.



Woods Tanning

• Uitenhage Area, South Africa

• Dyehouse supervisor, dyehouse colormatcher, general hand

  • Jan 1999 - Jun 2003

  Ostrich leather dye and color matching. Dry-cleaning crust leather. Dye house supervisor. Receiving raw skins. Customer service. Ostrich leather dye and color matching. Dry-cleaning crust leather. Dye house supervisor. Receiving raw skins. Customer service.