Based on your single use knowledge, you will evaluate systems, components, and applications by designing and manufacturing our equipment products (vessel, bags, tubing, manifold, connectors, piping, instruments, probes, liquid dispensing, filtration, chromatography, TFF, clarification, ).
Your main responsibilities will be :
Execute the design and development of Single-Use Systems (SUS)to be operated with complex electro-mechanical biotechnology to bring major improvement to our biopharmaceutical equipment such as : reduced cross-contamination risks, lower capital investment, elimination of cleaning and sterilization operations, reduced turnaround times, and the ability to scale an operation up or down with limited additional investment.
Select and develop all SUS to ease / improve Product compatibility, TSE / BSE, extractables and leachable study, chemical compatibility, endotoxin management, low bioburden or sterilization (heat or gamma irradiation), container closure integrity,...
Develop Good Engineering Practices and standards.
Provide guidance on standard selection / definition and validation protocol to support the team.
Build and maintain a database collection of parts and assemblies that may be used in our consumable products.
Create and perform DOE to develop a first understanding of key variables.
Develop SUS by studying customer requirements, researching and testing manufacturing and assembly methods and materials.
Define system and components capabilities and ensure the quality of the product by designing SUS testing methods, testing finished products and system capabilities and properties.
Inspect completed installations and observe operations, to ensure conformity to design, equipment specifications and compliance with operational and safety standards.
Develop manufacturing processes by designing and modifying equipment for building and assembling SUS taking into consideration operators' observations.
REQUIREMENTS / QUALIFICATIONS
BSC or Master degree in mechanical or bioengineering
3-5 years of experience in a Pharma or Biotech sector
Proven skills in time management and excellent oral & written communication skills
Experience in Biotech and / or pharmaceutical equipment design, particularly benchtop system using SUS is a plus
Fluent in English. French is an asset
Overall : you strive for excellence and focus on high-quality products, you are a driven team player and you feel at ease in the challenging and fast-paced biotech universe!