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Laboratory IT System Owner, GCLP Laboratory Lund

As Laboratory IT System owner at the laboratory in Lund at MinervaX, you will play a central role in the establishment of a GCLP laboratory for clinical samples from MinervaX’s prophylactic vaccine targeting Group B Streptococcus (GBS). You will be responsible for the software and IT used in the laboratory assuring systems are compliant with regulators requirements.

Your main responsibilities include:

  • Collaborating with external partners and colleagues for validation of laboratory software and systems.
  • Creating and updating documentation that meets the regulatory requirements within the GCLP area in close collaboration with the Director of Clinical Bioassays (e.g. CFR 21, part 11 compliance).
  • Full lifecycle system owner for computerized systems including ELN, LIMS, sample management systems, monitoring systems, laboratory equipment software, and similar.
  • Work closely with colleagues in the laboratory to establish good laboratory processes related to software and IT processes.
  • Responsible for general software updates and maintenance in the laboratory systems.
  • Ensure long-term storage of source data and data protection in laboratory systems.
  • Training of colleagues in the laboratory area in data integrity and the ALCOA+ principles.
  • Knowledge within CSV and GAMP is an advantage.

Your qualifications include at least three years of experience in the pharmaceutical and/or biotechnology industry with IT and software responsibility in a GxP controlled area. We are looking for a candidate with a minimum educational background as master, bachelor or similar. It is important you understand laboratory processes and are highly IT skilled and enjoy working with IT and software processes. Data integrity is a natural part of your daily vocabulary, and you strive for enabling simplicity for your colleagues in their daily laboratory routines. You will need to be proficient in written and oral English since this is company language.

You are a self-driven person that possess the capacity for independent and critical thinking. You must have organizational skills, IT skills, a high attention to details and a capability to understand the full data flow. You will engage with many people in lab and needs to have high collaborative skills. You will work in a company with a culture of innovation and a vision to work paperless in a GxP regulated environment. You will react fast on changes and take responsibility of your tasks with a high motivation and dedication.

MinervaX is a Danish biotechnology company, established in 2010 to develop a prophylactic vaccine against Group B Streptococcus (GBS), based on research from Lund University. MinervaX is developing a GBS vaccine for maternal immunization, likely to have superior characteristics compared with other GBS vaccine candidates in development. The latter are based on traditional capsular polysaccharide (CPS) conjugate technology. By contrast, MinervaX’s vaccine is a protein-only vaccine based on fusions of highly immunogenic and protective protein domains from selected surface proteins of GBS (the Alpha-like protein family). Given the broad distribution of proteins contained in the vaccine on GBS strains globally, it is expected that MinervaX’s vaccine will confer protection against virtually 100% of all GBS isolates.
Domicile: MinervaX Laboratory facility in Lund, Sweden.

For more details about the job or the company, please contact Rasmus.Bogo@knowit.dk/+45 2948 3820.

All applications must be in English and are treated confidentially.