Health Biotechnology, Pharmaceutical and Medical Industry

Positioned on the pharmaceutical industry and with medical device manufacturers, TEKJOB is involved in the design (mechanical, electronic or software), industrialization, testing and validation (QO, QI, QP) and Regulatory business activities.

Our teams are also present in the areas of quality, project management and production data supervision (MES).

PROJECTS

Management of an Immunodiagnostic Product Development Project On behalf of a world-class medical technology laboratory, our teams participated in the design and development of immunodiagnostic products.

  • Supply-Chain of pharmaceutical products and services.
  • Management of Quality transport.
  • Management : Quality studies department
  • Documentation management for project.
  • Technical Assistance.
  • Documentation Manager.
  • Weekly update of the project schedule (resources and associated specific costs)
  • Preparation and organization of meetings, weekly project teamwork sessions
  • Preparation and presentation of project reviews and documentation related to the process of mastering design / product development
  • Preparation and participation in a 510K pre-submission to the FDA
  • Ensure the achievement of business objectives in terms of cost / quality / time, compliance with international regulations and customer satisfaction.

Mechanical process project management

On behalf of a world-class medical technology laboratory, our teams were in charge of mechanical design on process-related machines (washing machines, dryers, etc.), project reviews, supplier monitoring, safety processes.

  • Proposal of technical concepts, ergonomic, CHSCT improvement
  • Mechanical design and CAD modeling with AutoCAD 2011, Inventor, drawing, consulting with suppliers
  • Implantation in clean room
  • Workstation layout, removal of musculoskeletal disorders (MSDs) related to heavy and repetitive operations
  • Multidisciplinary project: industrial computing, supervision, traceability, robotics, automatism, mechanics, image processing
  • Drafting of the functional specifications
  • Using the SAP PLM
  • Planning, burden sharing, task group meeting facilitation, design reviews and supplier development
  • Validation tests, repeatability and reproducibility
  • Validation of mechanical calculation notes, mechanical plans
  • FAT / SAT reception, QI / QO / QP qualifications

automatism

On behalf of the world leader in vaccine design, we intervene in support of the Automatism pole on projects for the creation of new buildings. This project consists of the creation of a new bacteriological unit for the production of products (vaccines, vials, syringes) for bacterial diseases.

  • Synchronization and calibration of sensors and actuators for modification of an automated vaccine production area
  • Update of functional analyzes to integrate the Manufacturing Execution System (MES)
  • Synchronization of the SIEMENS PLCs (input / output test) in STEP7 with the various sensors and actuators (transmitters of pressure, flow, level, temperature, end of stroke, valves, etc.).
  • Control system for vaccine production (fermentation, detox and harvest) on the future project.
  • FAT tests for verification and qualification tests of modifications applied under SIEMENS S7-400 H and 300 PLCs.

TRADES

  • Industrialization engineer and continuous improvement
  • IT Developer
  • Automation Engineer
  • Medical Risk Analysis Engineer
  • Equipment qualification engineer