Nos offres d'emploi

Process Engineer PHARMA (H/F)


Belgique

CVO/BE/ING/1016

EFOR-CVO is EFOR Group’s Life Sciences brand, a result of two major consulting actors brought together at the end of 2020: Efor Healthcare and CVO-EUROPE. We have decided to join forces to assist medical device manufacturers and pharmaceutical, cosmetic and biotechnology industries, in order to become the leader in the Life Sciences consulting sector.
Our group of over 1300 experts seeks to become the market leader by providing a unique approach to consulting across the full product development cycle of our clients’ business and products and who are subjected to stringent regulatory demands.
Together with the same international aspiration, we gather unique, committed and passionate women and men, working towards our clients’ performance.
Join us now !

To support our development, we are looking for :

Process Engineer PHARMA (H/F)

Permanent contract

Responsibilities
YOUR MISSION

Your mission will be to translate requirements from the customer and their specific vaccine manufacturing
process (URS) to requirements of the technical experts (FDS). As process owner, you will coordinate
technical inputs from different experts of the development team, develop testing strategy and investigate
in case of potential failure of the system (equipment and bioreactor).

YOUR RESPONSABILITIES

Based on you experience of the vaccine manufacturing process, you will participate from the design to the
validation of single-use manifolds and associated equipments. You will manage PI&D, bill of materials,
process definition and develop manufacturing procedure.
On a daily basis, you will carry out various engineering tasks, such develop Design of experiment on new
designs, risk analysis, define quality of products through the entire production cycle to ensure our systems
meet the global standards.
Your responsibilities will include, but are not limited to:

- Design new system or part of system
o Write Functional Specifications based on URS
o Develop Design of Experiment
o Write or review testing protocol
o Execute testing protocol
o Analyze data on a statistical point of view
o Write or review report
o Participate to Design Review

- Internal and external Investigation
o Owner of the investigation process

- Quality documentation
o Risk Assessment
o Definition of critical parameters and associated tests
o gather product requirements (e.g. functionalities, speed, safety standards)

- Technical coordination
o Ensure a good coordination with the manufacturing engineer’s, quality and logistic teams


Qualifications/Skills
• Master degree electro mechanical or bio engineering
• 2-5 years of experience in vaccine manufacturing or biopharmaceutical environment
• Excellent SUS and equipment associated to vaccine manufacturing process knowledge
• Proven time management, organizational, and oral & written communication skills
• Familiar with lean-SixSigma tools – Green belt is a must
• Excellent knowledge with root cause analysis
• Fluent in French or Dutch and English

OUR OFFER

• An international Leader Company in the Engineering, Validation and Quality sector, which offers you interesting project.
• A strong corporate culture ensuring a personal and professional blooming and self-fulfillment.
• Overall trainings and a personal career management.
• A good salary package with lot of extra legal advantages.

Interested ? Don’t hesited to send your CV.


publication date : 29/11/2021

  1. Mrs Mr



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