Juan Miguel Cubillas Fernández

Bis 2020, Validation Lead & Project Manager for MES, Prime4services GmbH

Karlsruhe, Deutschland

Fähigkeiten und Kenntnisse

active
adaptable
sociable
team-worker
flexible
Entscheidungsfähigkeit
Serialization
Pharmaindustrie
Project Engineering
Consultancy
Teamfähigkeit
Track and Trace
Packaging
MES
SAP Aii
SAP ERP
SAP ATT
QlikView
SharePoint
FAT-SAT Test Exectution
IQ/OQ
Process Validation
Computer System Validation
CFR 21 Part 11
GMP Compliance
GXP
GAMP 5
GS1
Audit Trail
PMP Certification

Werdegang

Berufserfahrung von Juan Miguel Cubillas Fernández

  • Bis heute 2 Jahre und 4 Monate, seit März 2022

    Consultant

    Prime4services GmbH

    MES – Implementation of new version of PAS-X (Core Concept) for a multinational (top 5) customer, DE – Leverkusen Tasks: o Develop test concept and test cases for System Test (System functionality) + UAT (Business Processes) as part of a Core approach o Creation of the different Test Cases to cover all of the risks and requirements by customer o Supporting the drafting of the TCs in DEV-system as well as the formal execution in Q-System o Support further rollout implementation required by customer

  • 5 Monate, Okt. 2021 - Feb. 2022

    Consultant

    Prime4services GmbH

    Development of Agile Project Management and Agile Concept in p4s environment o Create and develop a presentation as part of a primetime session for Agile Concept and Agile PM o Upskill and discuss with p4s colleagues about definition as well as advantages and disadvantages of agile projects for our company o Gather and consolidate information & experience by colleagues with Agile o Assessment of Agile PROS & CONS and evaluation of whether it can be adopted in a p4s environment

  • 8 Monate, Nov. 2020 - Juni 2021

    Project Manager

    Prime4services GmbH

    Internal project for implementing SAP ByD as ERP System o Coordinate with Anthesis the implementation of a prototype of SAP ByD as ERP System in prime4services (DE + IT) for the areas of Finances and Operations. o Control of the Budget & Timelines with supplier (Anthesis). o Internal coordination and support to collect la required data for the new system. o Internal coordination and support for the materialization of the corresponding key User Trainings, Test phases, Acceptance Test & System acceptance.

  • 6 Monate, Okt. 2020 - März 2021

    T&T Project Manager

    Prime4services GmbH

    Track & Trace - RFP Preparation phase for a top 5 customer, CH – Basel Tasks: o Control of budget and timelines of the project. o Continue coordination with Roche PM to control all the tasks and deliverables of the project. o Assessment of URS documentation package from Roche and combined with the STIPP template. o Supporting Ops/Life Cycle concept deliverable. o Creation of a questionnaire for Roche pilot sites to verify expectations with sites, based on key aspects of drafted URS and Ops / LC Concept.

  • 1 Jahr und 1 Monat, Okt. 2019 - Okt. 2020

    Validation Lead & Project Manager for MES

    Prime4services GmbH

    Project Manager for a MES project of a top pharmaceutical worlwide enterprise (HQ DE-Singen). o Supporting and managing the qualification and validation of a new MES System for a full integrated EBR capability o Design of the VP/URS/RA for right implementation o Supporting design/validation/qualification/implementation phases of new MES system o Supporting and managing the completion of all qualiifcation activities FAT / SAT / IQ-OQ-PQ

  • 1 Jahr und 10 Monate, Juli 2017 - Apr. 2019

    Project Manager for Serialization

    Prime4services GmbH

    o Qualification and validation of the serialization module in 44 packaging lines o Coordination with Vendors / Engineer Compliance / IT / QA and Production Departments for the right implementation and deployment of the serialization modules) o Supporting design/validation/qualification/implementation phases o Preparation and management of the budget, time ,quality and continuous changes of the project (including an audit at PM organizational level successfully accomplished)

  • 1 Jahr und 3 Monate, Mai 2016 - Juli 2017

    Validation Lead & Project Coordinator

    Prime4services GmbH

    o Support in system test execution (FAT-SAT, IQ/OQ) focused in 3rd level (Level) o Coordinating the support with engineer site / IT / QA and vendors for the qualification and validation of the line controller and server levels o Supporting design/validation/qualification/implementation phases of T&T/Serialization/Coding for packaging lines o Review and approval of qualification documentation (vendors, local & global)

  • 3 Jahre und 3 Monate, März 2013 - Mai 2016

    Project Engineer

    Prime4services GmbH

    Project Development / Consulting. Support of the current customer projects and sales leads, in the areas of Track and Trace and Manufacturing Execution System (MES). Project Engineer inside Global Core T&T Program of main division of a global Top-5 pharmaceutical enterprise (HQ CH-Basel). Location: Operation Base in Switzerland / Sites in Switzerland, Germany, USA, Turkey, Italy, Spain and China Responsibilities: o Support in project documentation management o Support in system test execution

  • 2 Monate, Mai 2012 - Juni 2012

    Laboratory engineer

    Beuth Hochschule für Technik Berlin

    Monitoring, review and verification of electrical equipment of the various food technology laboratories. Knowledge and application of food technology in dry and wet.

  • 6 Monate, Feb. 2011 - Juli 2011

    Researcher

    Krakow Technology University

    Researcher at the Krakow Technology University Laboratory as completion of the Final Project “Qualitative Comparison of Ginseng and Liquorice Active Compounds with Different Solvents and Methods”.

  • 3 Monate, Okt. 2010 - Dez. 2010

    Monitoring and verification of the various teams of process plants

    Cepsa S.A

    Monitoring and verification of the correct operation of the various teams of process plants at maintenance area of CEPSA Gibraltar-San Roque Refinery. Work with plant verifiers in the overhaul and repair of pumps, turbines, ventilators, compressors, heat exchangers and industrial refrigeration. Colaboration with process engineers on site inspections of cooling towers, chimneys and boilers.

  • Project Engineer

    Prime4services GmbH

Ausbildung von Juan Miguel Cubillas Fernández

  • 1 Jahr und 1 Monat, Okt. 2011 - Okt. 2012

    Postgraduate in Occupational Risk Prevention

    University Camilo José Cela (Madrid, Spain)

    With the three specialities (Expert in Occupational Safety, Industrial Hygiene and Ergonomics)

  • 6 Monate, Feb. 2011 - Juli 2011

    Chemical Engineering

    Krakow University of Technology (Poland)

    Completion of the engineering Final Project within the Free-mover programme, developed and presented in English at the Krakow University of Technology (Poland), obtaining the maximum final grade 5-A.

  • 1 Jahr und 1 Monat, Sep. 2007 - Sep. 2008

    Chemical Engineering

    UNIBO (Università degli Studi di Bologna, Italy)

    Control and instruments for chemical process and statistics methods with an Erasmus scholarship.

  • 6 Jahre und 11 Monate, Sep. 2003 - Juli 2010

    Chemical Egineering

    University of Cádiz (Spain)

    Chemical laboratories knowledge and skills. Electrical, mechanical and computer science (theory and practice). Management, maintenance and security in companies and industrial plants. Specialized in environmental issues and renewable energy.

Sprachen

  • Spanisch

    Muttersprache

  • Deutsch

    Fließend

  • Italienisch

    Fließend

  • Englisch

    Fließend

Interessen

Sports
playing piano
travelling

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