Overview
Join to apply for the Microbiologist Biocompatibility Manager role at Abylsen.
As part of the Abylsen Italy development, we are seeking a Microbiologist Biocompatibility Manager in the lifescience sector to join our team of consultants and bring your expertise to our projects.
What is the challenge?
Main Activities
* Be responsible for defining, supervising, managing and reviewing all microbiological analyses on products/semi assemblies, components, supplies, etc. (e.g. sterility testing, bacterial endotoxins)
* Validate all the sterilization methods processes according to applicable standards and manage the routine sterilization process
* Be responsible for the compliance and monitoring of manufacturing areas to the applicable standards classification (this includes hygienic rules definition for personnel and environment, cleaning solutions and program)
* Be responsible for the internal and external Laboratories activities
* Act as recognized master in all Microbiology/Sterilization/Biocompatibility matters on new products development and on the business continuity (e.g: supplier/process changes) to all CRM sites
* Accountable for the cleanroom qualification, monitoring (including trend analysis and management of nonconformities/CAPAs) and cleaning
* Develop and manage the team acting as a technical coach
Requirements
* Master degree in biology, Biotechnology or Science.
* Proficiency knowledge of pertinent standards related to microbiology, sterilization, environmental control and biocompatibility (e.g.: ISO 11135, ISO 14644-1&2, ISO 14698-1&2, ISO 11737-1&2, ANSI AAMI ST72, ISO 01993 series, etc.) to assure the process/documentation meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements
* Application of pertinent regulations (e.g., ISO 13485 and 21 CFR Part 820)
* Proficient in MS Office including Word, PowerPoint, and Excel
* English advanced level is a must
ABYLSEN is an international engineering consulting group with 3300 employees and a turnover of 290 M€ in 2023. Created by a number of entrepreneurs in 2005, the group operates in 30 locations across 7 countries (France, Italy, Switzerland, Spain, Luxembourg, Belgium and Netherlands).
As a multi-specialist, we are active in 8 main business sectors (Automotive, Aeronautics, Rail, Heavy Industry, Energy, IT/Telecom, Lifesciences, Banking/Finance) and bring our expertise to clients on innovation projects (R&D and operational performance).
Our consultants from engineering, IT & Lifesciences create solutions and develop their skills daily on diverse and enriching projects.
No barrier should hold talent back! Committed to equal opportunities, our Group is part of an inclusive approach: every position is open to everyone, and we actively support the integration of people with disabilities.
This announcement is addressed to all genders and all ages and nationalities, in accordance with applicable laws.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Consulting
Industries
* Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Abylsen by 2x
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