Microbiologist Biocompatibility Manager

Abylsen; Saluggia; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

An international engineering consulting group is seeking a Microbiologist Biocompatibility Manager to lead microbiological analyses and oversee laboratory activities. Candidates should possess a Master's degree in related fields and be proficient in microbiology standards and regulations. Strong management skills and advanced English are essential for this position located in Saluggia, Italy.

Competenze

• Proficiency in microbiology, sterilization, environmental control and biocompatibility standards.
• Experience with ISO regulations and documentation processes.
• Ability to identify effective compliance strategies.

Mansioni

• Manage microbiological analyses on products and components.
• Validate sterilization methods and ensure compliance.
• Oversee internal and external laboratory activities.
• Develop and coach the microbiology team.

Conoscenze

Proficient in MS Office

People management skills

Advanced English

Formazione

Master degree in biology, Biotechnology or Science

Descrizione del lavoro

As part of the development of Abylsen Italy, specialized in IT, Transport (automotive, aeronautics, defense, space and rail), Heavy Industry (metallurgy, steel plant) and Energy, we are looking for a Microbiologist Biocompatibility Manager in thelifescience sectorto integrate our team of consultants and bring your expertise on all 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 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 CRF Part 820)
• Proficient in MS Office including Word, Power Point, and Excel
• People management skills
• English advanced level is a must

ABYLSENisan international engineering consulting group with 3300 employees and a turnover of 290 M€ in 2023. Created by a number of entreprenors in 2005, the group was born from a common development ambitions across the major European regions and is now located in 30 locations spread over 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 all our clients on their innovation projects R&D and operational performance.

Our consultants from engineering, IT & Lifesciences, who create ingenious solutions, bring and develop their skills and know-how on a daily basis on projects that are as diverse as they are enriching!

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 both sexes, in accordance with Laws 903/77 and 125/91, and to people of all ages and nationalities, in accordance with Legislative Decrees 215/03 and 216/03