Microbiologist II

Overview

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we develop innovative diagnostic assays and instruments trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made possible through ongoing investments in research, positions us as a leader with a wide range of specialty solutions in the sector.

Why Join Diasorin?

• Impactful Work:
  Your contributions will directly impact patient care and make a meaningful difference in the world.
• Global Reach & Innovation:
  Collaboration with colleagues from around the world to contribute to global healthcare solutions at the forefront of the diagnostic industry.
• Diverse and Inclusive Culture:
  We value diversity and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team:
If you are passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We are looking for passionate and talented individuals ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team shaping the future of diagnostics? Apply today and join our exciting journey toward a healthier, more connected world.

Support the Operations teams as a subject matter expert in performing troubleshooting and investigation into Bioburden and Environmental failures. Strong working knowledge of quality system regulations/requirements and the ability to implement changes where necessary.

• Conduct routine analysis of products, stability samples, validation samples and Environmental samples through testing, data analysis/interpretation, method validation and continuous improvement projects.
• Develop, review and revise standard operating procedures.
• Train laboratory personnel on microbiological test methods.
• Initiate, investigate and execute NCRs, deviations, change plans and out-of-spec results as necessary.
• Consistently produce a high level of documentation accuracy and clarity according to cGMP documentation practices; author and review technical or quality methods, procedures, protocols and reports in accordance with GDP.
• Monitor trending of Bioburden and Environmental test results.
• Investigate and facilitate the solving of equipment/facility environmental and bioburden problems.
• Perform vendor sourcing and selection of supplies.
• Present technical information in formal settings.
• Perform equipment qualifications as necessary.
• Generate ideas leading to new or improved products and internal processes and help to implement where necessary.
• Perform other special projects and duties at the discretion of the immediate manager.

• BS/MS in Microbiology or a relevant field required
• 5+ years of experience working as a Microbiologist in Biotech, Pharmaceutical, Medical Device or cGMP regulated industry
• Experience with Bioburden/growth determination systems and aseptic methods; experience with gram negative and gram positive, anaerobic bacteria, environmental fungi identification and testing methodologies
• Strong knowledge of quality system regulations/requirements (FDA, EU, ISO, USP)
• Excellent written and verbal communication skills, excellent documentation and organizational skills
• Demonstrated critical thinking skills and attention to detail
• Ability to take ownership of assigned tasks and responsibility for the results
• Ability to perform multiple tasks
• Ability to work in a team environment and interact with various departments
• Ability to train others in the area functions needed for performance of job and review work for accuracy and alignment with procedures
• Intermediate proficiency in MS Word, PowerPoint and Excel, statistical programs (e.g. Minitab), Google Suites

• Work with biohazardous materials – Frequently
• Safety glasses, lab coat, surgical gloves are some but not all PPE requirements – Frequently

• 10%

The hiring range for this position is $80,000 - $100,000…