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. Furthermore, the Biopharma industry needs to be more sustainable and reduce its carbon footprint. Such challenges can be met with our continuous, digitized, and all-scale mRNA manufacturing approach. This ambitious venture project has strong technical foundations from co-founders, first class professionals from the most advanced biopharma players in terms of automation and mRNA technology, and from a solid IP background. 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.
As part of Dillico’s team, you will be responsible for the development of the GMP equipment, supported by process experts and the management.
- Proactively participate to the development of a cutting-edge technology for mRNA-LNP manufacturing.
- Build the user requirement specifications of our GMP solution.
- Perform detailed technical designs of our new equipment through an understanding of user requirements and through design review sessions with project stakeholders.
- Support all engineering development phases of the project to meet scope, schedule, budget, quality, and safety requirements. This work includes preparation of work documents, cost estimates, and project schedules.
- Manage design activities performed internally and with sub-contractors.
- Ensure materials of construction of manufacturing equipment are appropriate to meet process requirements.
- Lead the assessment of GMP devices to be integrated in the equipment.
- Manage and coordinate subcontractors in charge of manufacturing sub-systems of the equipment.
- Assist with identification and creation of preventative maintenance plans for maintaining manufacturing equipment.
- Assist with identification and procurement of spare parts required for plant maintenance activities.
- Assist the team with execution of FAT.
- Execution of commissioning and startup activities associated with CIP/SIP commissioning.
- Lead the edition of the turnover package documentation associated to the equipment.
Profile et experiences
A Bachelor / Master of Science degree in Chemical Engineering, Mechanical Engineering, or related engineering field.
5+ Years of experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
Experience in the design and operation of clean utility systems.
Experience with control systems including PLC and DCS.
Experience in the management and coordination of engineering consultants, equipment vendors and sub-contractors.
Demonstrated a mastery of technical drawings including PFDs, P&IDs, general arrangement drawings, and equipment design drawings is required.
Detailed knowledge of ASME Bioprocessing Equipment (BPE) guidelines.
Experience with pharmaceutical/biopharmaceutical manufacturing operations in a cGMP environment.
Knowledge of downstream unit operations associated with biopharmaceutical manufacturing including: chromatography, tangential flow filtration, sterile filtration, stainless steel and single use technologies.
Strong knowledge of sanitary design aspects of biopharmaceutical manufacturing equipment including Clean in Place (CIP) and Steam in Place (SIP) concepts.
Proficiency with troubleshooting of complex equipment and performing formal root cause analysis investigations.
Demonstrated ability to lead technical projects from concept through implementation.
You are recognized for your excellent communication skills and are able to cultivate a team and collaborative spirit.
Very good level of professional English required, Fluent level of French.
What we offer
A unique opportunity to participate in the development of an ambitious start-up where your contribution will be key to the success of the project.
You will be able to develop your career by working in a cutting-edge innovative environment where you will explore and innovate while working with diverse customers, teams, academics and industry leaders.
You will be empowered to take important technical and business decisions while working with a great team of experts.
Attractive working conditions:
- Stimulating work environment: pleasant offices, multicultural and motivated team
- Live and work in the heart of the Alps
- Lunch vouchers
- 50% of local transportation expenses reimbursed
- 7 weeks of vacation per year (including RTT)
- Top-of-the-range health insurance
- Opportunities to network and connect with experts worldwide (clusters)
Position located in Grenoble, France, one of Europe’s major high-tech clusters and the capital of the French Alps!