CV/Mission d'Ingénieur automaticien SIMATIC WinCC freelance

Exemple de missions de Julien,
Ingénieur automaticien SIMATIC WinCC habitant Paris (75)

• consultant belonging to the life sciences business

  EXPLEO GROUP Switzerland engineering & project
  Jan 2022 - Jan 2022

  ■ field of expertise: implementation of projects which aim at setting-up new equipment and automation systems for packaging lines and aseptic production, HVAC and utilities. Revamping projects with high business impacts.

• NALYS Belgium
  Jan 2021 - Jan 2022

  field of expertise: implementation of projects which aim at setting-up new equipment and automation systems for packaging
  lines and aseptic production, HVAC and utilities. Revamping projects with high business impacts.
  ■ customer: takeda.
  ALISPHARM Belgium
  engineering & project management consultant belonging to the life sciences business unit

• TOP PHARMACEUTICAL COMPANY Belgium
  Jan 2021 - Jan 2022

  projects: upgrade of a production room (data analysis for the critical attributes and process parameters). Upgrade of the data
  process management for serialization and aggregation on packaging lines. Setting-up a new detection system using deep learning so as
  to perform the automated control of packaging items. Setting-up a new cobot on a packaging line. Revalidation of a WFI distribution
  loop (data analysis for the critical attributes and process parameters). Validation of HVAC systems and temperature-controlled
  rooms.
  ■ assignment: technical responsible for several validation packages (vision systems, packaging equipment, serialization systems,
  HVAC, clean utilities, temperature-controlled rooms). Reviewer of SOP, User Requirement Specifications, Functional and Design
  Specifications. Responsible for the documentation framework implementation (SLIA, risk analysis, validation project plan, traceability
  matrix, design review, commissioning protocols, IO/OQ/PQ protocols, validation summary reports). Responsible for several validation
  packages (new Human Machine Interfaces) in order to implement a new serialization process (project linked to the global). Deviation
  management and troubleshooting.

• TOP PHARMACEUTICAL COMPANY Belgium
  Jan 2020 - Jan 2021

  ; projects: ensuring the information transfer from UCB to an integrator: definition of the specifications regarding the process
  functionalities for the new equipment USP and DSP. These specifications were used by the integrator to automate the functionalities
  under Siemens PCS7. The equipment were: 5 stainless-steel bioreactors, 3 stainless-steel vessels, 5 clusters of tanks for buffer storage
  (up to 8 tanks by cluster), 2 preparation vessels with their big bag station and homogenizers, 1 harvest centrifuge, 2 single-use
  bioreactors.
  ■ assignment: definition of the specifications for all functions which are used on the equipment. It included Cleaning in Place and
  Sanitization in Place. Reviewer of the specifications from suppliers (performed at the beginning of the mission).

• TOP PHARMACEUTICAL COMPANY Belgium
  Jan 2019 - Jan 2020

  projects: setting-up new single-use bioreactors and their automation system Siemens PCS7. Migration of the automation system
  Zeta to Siemens PCS7 for the overall production equipment of a Bio Pilot Plant.
  ■ assignment: responsible for the implementation of the validation strategy from the validation master plan. Responsible for the
  implementation of the validation documentation framework including the validation plan, IQ/OQ/PQ protocols, validation summary
  reports. Reviewer of GMP documentation: compliance check with SOP, GDP requirements. Responsible for the follow-up of the
  FAT testing. Responsible for the follow-up of the execution of the IQ/OQ tests during the qualification phase.

• TOP PHARMACEUTICAL COMPANY France
  Jan 2019 - Jan 2019

  ; projects: implementation of a project so as to set-up new packaging machines (unloading machine, labeler, bagging machine,
  cartoner with their vision and automation systems). Provisional budget: 3M.
  Implementation of a project in order to set-up new filter integrated testers for the remediation of data integrity gaps and to be
  aligned with the global policies.
  Implementation of a project so as to set-up new autoclaves (pre-studies).
  ■ assignment: technical feasibility studies for projects and budget validation. Writing of the specifications. Launching of tenders and
  selection of suppliers. Implementation of the provisional schedules.

• ALISPHARM Belgium
  Jan 2018 - Jan 2021

  field of expertise: implementation of projects which aim at setting-up new equipment and automation systems for packaging
  lines and aseptic production, HVAC and utilities. Revamping projects with high business impacts.
  ■ customers: catalent, gsk, msd and ucb.

• TOP PHARMACEUTICAL COMPANY Belgium
  Jan 2018 - Jan 2018

  projects: setting-up a new robot STAUBLI on a filling line of syringes and working under Siemens Simatic WinCC (Tia Portal).
  ■ assignment: project management from the kick off up to the first batch. Definition of the objectives and deliverables, scheduling,
  coordinator and facilitator. Writing of the documentation frameworks for the commissioning, qualification and validation including
  risk assessments and specific protocols for 21 CFR Part 11 validation. Change control, deviations and CAPA management. Evolving
  in staff training after the implementation of the project.

• INDUSTRIAL START-UP France
  Jan 2014 - Jan 2018

  company overview: industrial start-up founded in 2014 and specialized in the development of soaps and biocidal products which
  are packaged with multi layers patented films (patent owner).
  ■ assignment: ensuring the development of new products in accordance with the EC regulations. Certification of products (ISO
  14024). Raw material sourcing. Development of a VBA software to automate tasks for the production. Management of audits
  by the regulatory authorities. Quality assurance. Technical support to the production team. Management of toxicological and
  microbiological studies (external laboratories).
  SOPRA GROUP, now part of SOPRA STERIA Nantes, France
  software development engineer belonging to the defence & security business unit February 2013 - February 2014
  ■ project: upgrade of software.
  ■ assignment: technical support to the users. Development of patches in W-language and realization of the unit tests. Translation of
  functional specifications into software qualification tests under HP Quality Center. Maintenance of the technical documentation as
  part of the CMMI framework.

• RHODIA, now part of SOLVAY Milan, Italy
  Jan 2010 - Jan 2012

  r&d engineer - v.i.e international internship program for the agro business unit project: technical support to EMEA customers.
  ■ assignment: research for new green solvents. Formulation of agrochemicals so as to deliver tailored solutions