Experience

Anaconda BioMed

• Spain
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior R&D & Design Control Engineer

  • Nov 2018 - Present

  Design Control and Validation (Product Verification of Specifications and Validation of use). Tech Transfer. Transport and Packaging Validation. EO Validation Specialist. Equipment Qualification and Process Validation (Special Processes). Lab Manager. Design Control and Validation (Product Verification of Specifications and Validation of use). Tech Transfer. Transport and Packaging Validation. EO Validation Specialist. Equipment Qualification and Process Validation (Special Processes). Lab Manager.



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Projects and Qualifications Engineer

  • Nov 2017 - Oct 2018

  Respimat® project is not only a qualification project but a large scale custom made project starting from zero. Respimat® Project is the construction of the new manufacturing site installed in Boehringer Ingelheim Sant Cugat del Valles Facilities where new PL3 and RESP5 lines will be located. A new brand Facility for the integration of one compounding, filling and finishing (primary packaging) Line with two Packaging lines for the distribution of Respimat® products all around the world. A new project, a new beginning, new people organized in multidisciplinary teams sharing knowledge and expertise with one common goal. Finalize the project on time fulfilling all milestones, going through all audits for product and manufacturing registration in order to produce, distribute and sell high-value pharmaceutical products to the market. - In charge of the Packaging Beginning of line Qualifications equipment for specific custom-made machines for RESPIMAT Packaging Line 5 - Specific custom made Protocols and Strategy Qualification Design. - Management of the consultancy team for the Project Qualification Equipment - Involved in installation and design activities with Specialist Project engineer - Involved in designing Process qualifications strategy with PPT and QA departments - Involved in CPP and CQA control strategy with PPT and QA departments - Involved in the realization of Risk Assessments for equipment and process - Involved with production and maintenance team for defining and improving equipment. - Team member for improving local qualification strategies on site. Show less



PQE S.r.l.

• Pharmaceutical Consultant

  • Oct 2015 - Nov 2017

  Working on a consultancy is giving me the opportunity to work as a Validation Engineer Specialist for different companies in Spain as well as in foreign countries (India, USA, Mexico). Based on FDA an EU Guidelines we ensure a correct development of validation procedures for facilities, equipment and processes in Laboratories and Pharmaceutical Manufacturing Lines. Furthermore, the management of the projects is our full responsibility, making sure that all implicated parts deliver their job correctly and in time. - Project Management, QA Validations Management, CAPA Management and Change Control Management - Commissioning and Qualification of Pharmaceutical Facilities (HVAC, Facilities and Services) - Life Cycle Validation - Equipment Qualification and Process validation (IQ, OQ, PQ) - Computer System Validation (IQ, OQ, PQ) - Cleaning Validation - SOP’s Definition - Definition and Execution of Protocols. - Impact Assessment and Risk Assessment - Serialization Expertise. - GxP, FDA and MDD environments (Pharma and Medical Device environments) - Highlighted companies for which I worked: Novartis, Boehringer Ingelheim, Almirall and Akorn Show less



St Giles International

• United Kingdom
• Higher Education
• 1 - 100 Employee

• Administrative Assistant

  • May 2014 - Apr 2015

  During this period I dedicated my time to improve my level of English language and communication skills among others studing and working at the school. This helped me to expose my ideas in a more structured and clear way to achieve a better team work environment in the future and also to comunicate in a more concise manner. As a Project Leader, to adquire this kind of skills is really important because english is the carrier language of most companies and it is essential to know how communicate well in order to develope your job perfectly. My tasks at the school were: - Support to coordinate the Social Activities Calendar for all students - Provide information about English courses to prospective students - Support students with information about the school, the city and the country - Inventory of student materials - Support to the Director of Studies, the Registrars and Administrative personnel. Show less



B. Braun Group

• Germany
• Medical Equipment Manufacturing
• 700 & Above Employee

• Project Leader R&D, CoE Closure Technologies

  • Nov 2011 - May 2014

  As Project Leader I had to carry out R&D projects from initial phase (design and prototyping) following Customer Requirements from MKT, posteriori approval and Technology transfer from R&D to Engineering in order to assure a correct and feasible industrialization of the new products going through different departaments like QA, QC, SCM so as to coordinate efforts in one single direction to fulfill stablished deadlines and to have a reliable product.- Project Management- Person in charge of surgical needles developments- Person in charge of relationships between the company and the needles manufacture of the company, located in France- Improvement of actual products in order to ensure the actual position in the market and achieve new ones- Development of new products- Coordination of projects between the company and tech partners in order to ensure total compliance with agreed targets- Patent studies (freedom to operate studies)- Clinical trials with animals (protocol and site feasibility assessments)- Managing of interdepartmental and multidisciplinary teams- Managing of development and tech transfer projects- Process and Product Engineering- Research on new materials and manufacturing techniques- Follow- up of competitors- Assist in the development of new packaging containing needles- Provide technical support to the sutures development group- 6Sigma Project Co-leader (2 implemented measures)- Equipment qualification and process validation (IQ, OQ, PQ)- Drafting of technical documents for Regulatory purposes- Quality Assurance for products and processes.- R&D Laboratory Management Show less

• Laboratory Technician R&D, CoE Closure Technologies

  • Jul 2010 - Oct 2011

  - Person in charge of the chemical laboratory, compliance with GLP- Conduct physical, chemical and biological studies in new products- Characterization of internal and competitors products- Feasibility studies on modified and new products- Development and validation of analytical methods- Kinetic release tests- Antibacterial activity tests- Development and implementation of new characterization tests- Coating processes- Research studies- Kinetic release tests- Degradation tests- Development and validation of antibacterial tests Show less