CSV manager (f/m/d)
Coriolis Pharma is a globally operating independent service provider for formulation research and development of (bio) pharmaceutical drugs (proteins, peptides, monoclonal antibodies, RNA/DNA etc.) and vaccines. An interdisciplinary team of highly qualified scientists with many years of experience in the development of (bio) pharmaceuticals supported by an expert scientific advisory board provides cutting-edge service and know-how related to the formulation development of biopharmaceuticals.
At Coriolis, our scientists work in modern laboratories with a wide range of cutting-edge instrumentation. In the Data Science unit, we are right now spearheading the transition into a paperless lab to match our future ambitions within the field of data science. To support this transition, we are looking for an experienced computerised systems validation manager (CSV manager) to join our team
As CSV manager you will be responsible for overall computer system validation of our new Lab IT platform comprising LIMS, ELN, and customized instrument integration drivers.
Your first task will be to provide input to user acceptance tests (UAT) during the contracting and implementation. You will then assist the implementation by validating the system and help us drive the successful roll-out across the organization. This involves a broad range of interesting tasks, such as writing test scripts, validating data parsers for scientific instruments, change requests, risk management, and documentation. On a daily basis, you will be responsible for the continuous validation of the system when new instruments are acquired, software functionality extended, etc.
Other responsibilities include:
- Perform initial risk assessment of the software platform
- Support the creation of a proper user requirement specification
- Review project documents (operational qualifications, etc.)
- Approve changes and deployments from a validation perspective
- Define and review standard operating procedures relating to the lab IT platform
- You have previous experience in risk assessment of laboratory IT systems.
- You have work experience from a CRO, biotech, or pharmaceutical company where you gained experience with system validation
- You can communicate clearly in English – orally and in writing
- You enjoy validating computer systems in an efficient and agile manner
- Documenting your work comes natural to you and you like to support other people
- You have a background in IT management, the natural sciences, life science informatics, or similar discipline
- Previous experience with GMP and ISPE GAMP 5 is desirable but not required
What we offer you
As CSV manager at Coriolis, you will join a highly motivated, interdisciplinary team performing contract research and development for customers from the (bio) pharmaceutical industry worldwide. You will be part of a vibrant scientific culture and interact with international scientists to translate their needs into effective and innovative software solutions. Extensive on-the-job training and participation in vendor seminars and conferences will prepare you well for your tasks and keep you up-to-date on emerging technologies.
The position as CSV manager offers diverse tasks, which ensure that no two days are alike as well as the unique opportunity to shape a growing scientific IT organization. We actively support your personal development especially by training in relevant technologies and participation in conferences. Beyond that, Coriolis offers a variety of benefits, flexible workhours, and team activities to all employees. We are located in the southern part of Munich.
Please visit our website for further information: www.coriolis-pharma.com