Microbiology and Biocompatibility Specialist

Fortil is an engineering company founded in 2009. We support our partners in the success of their technical projects in various fields such as Industry IT or Healthcare.

Today we are more than 2000 employees spread over 11 countries. Working with us means working in an ambitious team within a multicultural and international context!

Our ambition is to contribute to building a more responsible communal and inclusive world for our employees and clients.

We are currently looking for aMicrobiology and Biocompatibility Specialistto support one of our projects nearTorino (biomedical sector).

Within the Quality department Centre of Excellence you will report to Microbiology & Biocompatibility Manager. The Microbiology and Biocompatibility Centre of Excellence is responsible to:

• validate and maintain the sterilization validations of devices manufactured
• demonstrate and maintain devices biological safety.
• guarantee the compliance of all clean rooms to the applicable standards.
• participate to the ISOMedtech groups for standards review.
• be reference for the Company device materials definition and physical/chemical properties.

You will be involved in a wide spectrum of activities and you will have the opportunity to learn on the job and with specific trainings to cover your missing knowledge.

It is the responsibility of the Microbiology & Biocompatibility specialist to manage sterilization and microbiological services under the manager supervision and in collaboration with peers.

All the analysis are entrusted to external qualify Suppliers: the frequent and positive collaborations with external Laboratories is part of the daily job activities.

YOUR MISSIONS WILL BE AS FOLLOWS

• participate to the definition of device cleaning procedures ; manage the routine sterilization process;
• review of all microbiological analysis on products/semi assemblies components supplies etc. (e.g. sterility testing bioburden bacterial endotoxins) defining and managing when applicable testing to be performed and validating new methods in collaboration with the external Laboratories when required ;
• guarantee the compliance and monitoring of manufacturing areas to the applicable standards classification : routine environmental controls management/review hygienic rules definition for personnel /environment and related trainings cleaning solutions and cleaning program; validation of all the sterilization methods processes according to the applicable standards;
• provide support in all Microbiology/Sterilization/Biocompatibility matters on the products business continuity (e.g: supplier/process changes);
• participate to ensures that all processes under Microbiology and Biocompatibility function duties are compliant to QMS requirements and GMP ;
• frequent use and application of technical standards engineering principles theories concepts and techniques as well as statistical elements ;
• analyze processes data for trends and communicating to peers and management to identify issues and improvement opportunities ;
• participate to development reviews and approval of quality system procedures investigation (e.g. corrective and preventive actions) and audit responses ;
• develop and maintain effective relationships with internal personnel and external stakeholders to facilitate and drive the resolution of regulatory compliance and product quality issues ;
• manage and document the department not conformances according to Quality System requirements documenting appropriately the root cause analysis (according to adequate quality tools) and define and implement corrective actions and verifications.

As part of the COE group you will be involved in:

• participate to the definition of the devices biological evaluation plan and report as well as reviewing biocompatibility test reports and chemical characterization/toxicological assessments.

As part of the Quality Team:

• participate to the CAPA system and subsystem by trends analysis driving root cause analysis and risk management activities as necessary ;
• assist on quality audits;
• leads effective meetings conducts presentations keeps quality records meeting minutes and action items including follow up

YOUR PROFILE

• Scientific Masters degree: Biology Biotechnology Chemistry CTF etc.
• Knowledge of the standards related to sterilization (mainly ISO 11135 and ISO 109937) and microbiology.
• Excellent written and verbal communication skills.
• English advanced level is a must.
• Proficient in MS Office including Word Power Point and Excel.
• Strong interpersonal skills.
• Attention to details sense of responsibility.
• Attitude to the use and application of technical standards engineering principles theories concepts and techniques as well as statistical elements.
• Ability in issuing validation protocol/reports data trend technical rational assessments etc.
• At least three years of experience in the sterilization validation department of a biomedical company; experiences in another highly regulated environment can be considered as well. Higher experience may be considered for a senior role with less supervision.
• Problem Solving: provides technical solutions to a wide range of difficult problems. Solutions are imaginative practicable and consistent with organization objectives and applicable standards.
• Latitude: works under manager supervision. Follows established procedures. Work is reviewed for soundness of technical judgment and overall adequacy. Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
• Interaction: Frequent interorganizational and outside customer contacts.

Next Steps

• Someone from the Talent Acquisition department will contact you to schedule an initial HR interview.
• If successful a second interview will be conducted to validate your technical knowledge.
• In case of a positive outcome from the technical interview there will be a last qualification meeting with the Client.
• If the final outcome is positive we will discuss our proposal with you. Alternatively if the outcome is negative we will share our sincere feedback!
  
  

Why Fortil

Although we currently find ourselves in a significant phase of expansion the high standards of our projects and recruitments remain as demanding as ever. Quality will always take precedence over quantity as we prefer excellence to ease!

We hope to become the largest independent engineering group in Europe working to serve future generations. To do so our operational model is based on four fundamental aspects:

• Profitable performance
• Expert engineers
• Efficient organisation
• Social responsibility
  
  

Apply and join us to become part of a model that is out of the ordinary!