Sr. Microbiologist

Placering
Roskilde
Fjernarbejde
Fully Onsite
Work Schedule
Other

Environmental Conditions
Office

Job Description

Job Title: Sr. Microbiologist, Technical Quality
Reports To (title of manager): Technical Quality Manager
Career Band: 6

Position Location: Roskilde

Day/Shift (if applicable): Day shift

When you are part of the team at Thermo Fisher Scientific Roskilde site, you will do important work, which will impact patients’ quality of life using our products for IVD or IVF and also helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. This role sits within our Technical Quality Team, from where your work will have real-world impact, and you will be supported in achieving your career goals.

Job Summary
The Sr. Microbiologist is our SME on several topics and will be the go to resource within our organization for microbiological quality questions, e.g. during production, nonconforming and complaint handling.

You will succeed in the role when you support operation, product management, R/D and quality to ensure the best possible experience for our customers. As a specialist you will cover and provide daily support to a range of colleges within operational quality and production, e.g. in connection with biological method/test validation. You will have contact to all functions onsite and to some corporate specialist functions on a less frequent basis.

About the job
Responsibilities:

• Lead QA activities to optimise documentation for sterilization and surface modification
• Support development and maintenance of test-methods, sampling plans, equipment, protocols, instructions etc. using statistical techniques to ensure compliance with regulatory requirements and relevant standards
• Participate in validation and qualification of software, processes, test methods at our in-house gamma irradiation plant according to international sterilization standards
• Participating and driving of projects with focus on quality improvements or quality documentation e.g. shelf-life testing, process improvements lean and practical process improvements PPI
• Conduct and support root cause analysis during complaint handling, CAPA and NCM/OOS
• Training of other employees at the site, in relation to quality - biology related issues ensuring that we can improve the level of knowledge in general at our site.

What will you need/what are we looking for?
Ideal candidates will have some degree of knowledge of regulation such as ISO 11607, ISO 11137, GMP/GDP, 21CFR820, relevant ISO management systems and risk management systems.

Experience in working in laboratories in either medical-devise or the pharma business or at suppliers to said business types. This could cover working with single use device and sterilization processes such as Gamma / E-beam /autoclaves.

A candidate with a Bachelor’s Degree in micro-biology (or equivalent experience). And your post graduate training may cover production relevant areas such as lean/PPI, systematic problem solving, project management and good documentation praxis.

You can inspire and motivate a cross functional team as project leader to achive your goals and have good communication skills both in Danish and English.

Traveling may be required up 10 %.

What are the benefits?
We are a Fortune 500 company and maintain a pay-for-performance culture. We provide an extensive onboarding program and continued training throughout your career. Access to the most important scientific research laboratories in the organisation. We offer flexible work arrangements and many personal growth opportunities within a multifaceted organization.

• Excellent basic salary plus bonus, Private healthcare, and a good cantina on site,
• Thermo Fisher Scientific offers employment within an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

At the local site there will be possibility to use a newly established gym. And we have a well functioning employee club arranging many social activities.