Senior Sterility Assurance Engineer 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

We are seeking a skilled Senior Sterility Assurance Engineerwho ispassionate aboutguaranteeing the conformity of aseptic processes by managing and improving it to ensure :

• The QMS is in compliance with all applicable aseptic standards and regulations;
• All production activities are in compliance with the companys QMS;
• All released batches are conforming.

Duties & Responsibilities

1. Collaborate on the continuity and compliance of the QMS to applicable aseptic standards andregulations
   1. Participates in global risk assessment activities
   2. Ensure that sterilization processes (internal and subcontracted) are compliant with applicable standards and regulations ISO 11137 for sterilizationby gamma radiation and ISO 11135 for sterilization with ethylene oxide.
   3. Participates to CAPA NC and Change Control processes to guarantee the continuous improvement of the QMS
   4. Performs raw material semifinished final product batch release and sterilization release.
2. Maintain the compliance with the QMS for all aseptic production activities by:
   1. Participating to medial fill test strategy definition and to periodic media fill tests;
   2. Participating to aseptic training process of the personnel;
   3. Ensuring that only qualified persons participate in the aseptic process;
   4. Ensuring environmental control of clean rooms and products;
   5. Ensuring that all site aseptic batch records anomalies are identified and investigated and that only conforming products are released;
   6. Ensuring that production documentation is adequate; Managing the aseptic risk assessment activities;
   7. Ensuring support to the different departments.

YOU WILL LOVE THIS JOB IF

• You are autonomous and detailed oriented;
• You are dynamic and proactive;
• You can understand complicated processes and understand the associated documentation needs;
• You have good knowledge of sterilization processes;
• You have good communication skills (both oral and written) in English;
• You are competent in interactions with executive management regulators and suppliers.

YOUR BACKGROUND

• Engineering Degree or equivalent;
• 710 years minimum experience in aseptic production processes;
• Experience in Quality in a pharmaceutical company and in a production environment;
• Working knowledge of GMP annex 1 FDA Sterile Drugs Produced by Aseptic ProcessingISO 13408 and FDA (FDA 21 CFR part 820) regulations;
• Good knowledge of sterilization processes;
• Good communication skills (both oral and written) in English;
• Competent in interactions with executive management regulators and suppliers.

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;
• 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 HR interview with Talent Acquisition Manager (30 mins)
• Then a Managers Interview where you will meetthe Manager of the department you are applying to join (1 hour)
• This will then be followed by a technical interview to validate your practical jobrelated skills (1 hour)
• For the very final round you will be invited to an onsite interview tomeet the team for a team and culture fit interview.
• In certain instances you may 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.