Process Manufacturing Engineer

Posted Date: 03-Aug-2022

Location: Eysins, VD, CH, 1262

Company: Quotient

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins / Switzerland, Edinburgh / Scotland and Chicago / Illinois.

 

PROCESS MANUFACTURING ENGINEER

 

Quotient is recruiting for a Process Manufacturing Engineer to join the Manufacturing team based in Eysins. The role is a full-time and permanent position.

 

The Process Manufacturing Engineer will act as the primary interface between the Quotient MosaiQ development and technology transfer teams, MosaiQ system and manufacturing and maintenance teams.

He/She will develop a clear understanding of the MosaiQ Microarray manufacturing process to be able to advise on all critical quality aspects of the product.

 

The Process Manufacturing Engineer will provide expertise on process design, development, and validation to develop, in conjunction with the Quality and Regulatory Affairs team, a quality control system for the Microarray manufacturing system.

 

 

JOB DESCRIPTION
The main responsibilities will include:

  • Interpret critical to quality microarray parameters and ensure that these are incorporated into the manufacturing system design
  • Use statistical techniques to develop a manufacturing process control system to assure high quality while maintaining the required production volumes
  • Work closely with Quality and Regulatory Affairs personnel to create an appropriate validation plan in and to assist with generation of data required for regulatory submissions
  • Establish and maintain the required documentation (e.g., IQ/OQ/PQ, Process Maps, FMEAs, WI) in assigned scope of process
  • Drive projects with established CAPEX and scope in relation with technology improvement, process industrialisation, increase robustness and seamless execution
  • Investigate product and process related Non-Conformances or Customer complaints and act on established CAPA as required
  • Increase the manufacturing capacity and performance of the production line

 

QUALIFICATIONS & EXPERIENCE REQUIRED

  • EPF/HES Engineer in Micro Engineering / Electronics, Science or equivalent degree
  • At least 5 years of experience in a regulated manufacturing environment (pharma, biotech, medical devices)
  • Experience with plastic and glass assembly systems is an advantage
  • Experience in Lean 6 Sigma and Allen Bradley PLC programming is an advantage
  • Exposure to Compliance Regulations (e.g., GMPS’s, audits)
  • Excellent communication skills (oral and written)
  • Team player, rigorous, and flexible
  • Ability to work under pressure and meet deadlines
  • Fluent in French and English