The Project

mRNA is an extraordinary opportunity to provide vaccines and therapies in a record time and at the right cost and place, especially in countries that have been poorly served up to now.

Such a fast-to-develop technology should go with a fast-to-scale manufacturing process, offering highly flexible capacity. Additionally, the Biopharma industry needs to be more sustainable and reduce its carbon footprint.

For meeting such requirements, Dillico is developing a continuous, digitized and scale-up-free GMP mRNA manufacturing equipment.

This ambitious venture project has strong technical foundations from the co-founders, with experiences in major biopharma players, and from a strong expertise of the R&D team – the project benefits also from strong IP assets.

We are working to develop a solution which serves both the biopharma industry and the people, including LMICs, through intensive exchanges and partnerships with key players.

Responsibilities

The Industrial IT engineer will work on the development of the Inline Digital Twin of the innovative end-to-end mRNA-LNP manufacturing equipment (upstream, downstream and formulation). This tool will be a set of applications to transform the data collected from all the devices to valuable knowledge for all the users. Reporting to the COO, you will be responsible for defining/implementing/adjusting the IT strategy, supervising/participating in the software development, and performing commissioning, qualification and product testing activities.

You will be involved at all stages of the development, from pilot to the final commercial equipment.

– Reviewing/approving and/or writing Functional Analysis, FAT/SAT/IQ/OQ protocols and reports (Factory Acceptance Test, Site Acceptance Test, Installation Qualification, Operational Qualification) in GMP and Non-GMP environments and ensuring their consistency
– Managing subcontractors, ensuring that the work is carried out in accordance with the specifications, taking delivery of subcontracted work in compliance with QSE rules
– Setting up and monitoring the receipt and checking documentation
– Following suppliers for documentation (in conjunction with the purchasing department)
– Participating in and/or supervising technical tests and ensuring their consistency
– Adjusting the code when required to implement improvement
– Providing expertise in the search for solutions and contribute to build the foundation of the customer support team
– Improving the overall performance by proposing improvements and innovative solutions, as well as monitoring technological (software/tools) and regulatory developments in automation and commissioning/qualification
– Supporting mRNA drug substance and drug product process development and manufacturing activities for our partners / customers
– Communicate internally and externally through meeting with partners and at exhibitions/conferences
– Collaborate with the Modeling, Analytical, Process Development and Process Engineer people to design the GMP-prototype (control strategy, ergonomic etc.…)
– Taking part in supplier qualification and/or follow-up audits ensuring that non-conformities are dealt with.

You are also responsible for the technical, safety, schedule and organizational aspects of the IT part of the business in front of the customer, in compliance with the contractual clauses.

Profile and experiences

The successful candidate will have significant experience in highly digitalized pharma or biotech or “design and built” engineering company or OEM or service company.
– >5 years of experience in the relevant industry
– Proven experience in setting up data mining, data processing and statistical report
– Expertise in Dashboard software (Tableau, Spotfire, …) and Electronic Batch Record software ( Infobatch…)
– Expertise in communication protocols (CC-Link IE TSN, Profinet, Modbus TCP, OPC UA)
– Expertise in Data historian / PAT software (SIPAT, SynTQ,…) and data base architecture
– Knowledge or Expertise in PLC/DCS/MES (Siemens/Emerson) would be a plus
– Innovative mindset, team player who fosters collaboration
– Strong communication and collaboration skills, and examples of leadership in project management
– Proactive, eager to learn, agile and curious about startup and deeptech environments

What we offer

A unique opportunity to take part of the development of a start-up where your contribution will be key to the success of the project.
You will be able to grow your career by working in a state-of-the-art innovative environment where you will explore and innovate while working with diverse clients, teams, academic and leaders in the field.
You will be empowered to take important technical and business decisions while working with a great team of experts.
Attractive work conditions:
– Stimulating work environment: multicultural and motivated team
– Live and work close to the Alps
– Lunch vouchers
– 50% of local transportation costs paid
– 5 weeks of holidays per year + 2 weeks of compensation time (RTT)
– Industry-leading healthcare
– Opportunities to network and connect with worldwide experts (clusters)

Position located in Grenoble area, France, one of the major high-tech hubs in Europe

Send your application including CV at hr@dillico.com