Quality Technician Microbiology amp Sterility MFX

DESCRIPTION OF THE COMPANY

Tissium is a missiondriven medical device company founded in 2013 headquartered in Paris with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop new innovative solutions in surgery for a positive impact on patients lives.

Tissiums technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Womens Hospital) who cofounded the company with Christophe Bancel (CEO) and Maria Pereira (Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today these polymers are used for structureless nerve repair hernia repair and cardiovascular sealing

Since our inception we have raised a total of 170 million euros. Our latest fundraising round which concluded in April 2023 resulted in 50 million euros in additional funding. This infusion of capital provides us with the necessary resources to finance the commercialization of our first products.

RESPONSIBILITIES

The Quality Technician in Microbiology and Sterility Assurance is responsible for conducting microbiological testing and sterility assurance activities to ensure that products comply with regulatory standards and company quality specifications. This role involves working in a laboratory setting to perform tests on products raw materials and environmental samples to detect the presence of microorganisms.

Microbiological Testing:

• Perform microbiological assays such as bioburden testing endotoxin testing microbial identification and sterility testing.
• Prepare samples and culture media for testing.
• Analyse and interpret test results ensuring they meet the required specifications.

Sterility Assurance:

• Monitor and validate sterilization processes including heat radiation or chemical sterilization methods.
• Conduct environmental monitoring of clean rooms and controlled environments to ensure compliance with sterility standards.
• Participate in the qualification and maintenance of sterilization equipment and processes.

Quality Control and Documentation:

• Maintain accurate and detailed records of all testing procedures and results.
• Ensure that all laboratory work is documented in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Report any deviations or nonconformances to the Quality Assurance team and assist in the investigation and resolution of issues.

Equipment Maintenance:

• Perform routine maintenance and calibration of laboratory equipment.
• Ensure that all equipment is functioning correctly and troubleshoot any malfunctions.

Regulatory Compliance:

• Stay uptodate with regulatory requirements related to microbiology and sterility assurance.
• Assist in the preparation of documentation for regulatory submissions and audits.

Continuous Improvement:

• Participate in the development and implementation of quality improvement initiatives.
• Recommend changes to procedures and protocols to enhance laboratory efficiency and compliance.

The employee shall apply all regulatory requirements in place at Tissium by applying Tissium Quality Management System documentation.

REPORTING LINE

This job will report to the Quality Director.

YOU WILL LOVE THIS JOB IF

• You have strong analytical and problemsolving skills.
• You possess excellent attention to detail and organizational abilities.
• You are proficient in the use of laboratory equipment and data analysis software.
• You have good communication skills both written and verbal.

YOUR BACKGROUND

• A degree in Microbiology Biology or a related scientific field.
• 35 years of experience working in a microbiology laboratory preferably in a quality control environment.
• Knowledge of microbiological testing techniques and sterility assurance practices.
• Familiarity with GMP GLP and other regulatory guidelines.

WHY JOIN US

• A work culture that values urgency a willingness to take risks a desire to learn an ability to challenge norms and a capacity to operate within a dynamic range;
• A competitive salary;
• 50% reimbursement of transportation expenses;
• The flexibility to work in Paris Roncq or a hybrid arrangement;
• An international work environment with team members from over 13 different nationalities reflecting Tissiums commitment to diversity and its inherent strengths;
• An opportunity to join an ambitious startup striving to address one of the most persistent medical challenges since the inception of surgical procedures.

HIRING PROCESS

• The journey starts with an interview with Talent Acquisition Manager (30 mins)
• Then a facetoface (virtual) meeting with the Manager of the department you are applying to join (1 hour)
• This will then be followed by a case study or business case to validate your practical jobrelated skills (1 hour)
• For the very final round you will meet other teams in Tissium
• You will be asked to provide us with professional references including contact details.

Intrigued Wed love to hear from you! Apply today were standing by for your resume!

We firmly believe that building a company for everyone requires a diverse team. Our organization values diversity and welcomes applications from individuals of all backgrounds. We do not discriminate against employees or applicants based on gender identity or expression sexual orientation race religion age national origin citizenship disability pregnancy status veteran status or any other differences. Our company culture prioritizes human interaction and ensures that every individuals voice is heard making our processes lightweight yet efficient.