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Senior Engineer* Systems Architecture Digital Solutions Quality
As the Architect for the analytical part of our mRNA based individualized cancer therapy, you have the opportunity to shape the future of our laboratory system landscape. Align with stakeholders, build a vision for where we need to be in 3 to 5 years and guide the organisation to shape the system landscape accordingly.
Collaborate with business stakeholders and other IT teams to identify and technology needs and opportunities
Ensure that solutions are aligned with the overall enterprise architecture and technology strategy
Define quality goals and scenarios for your domain
Guide and support the engineering teams to set up the systems to meet those goals
Prepare architecture decisions based on the defined quality scenarios and coordinate them with the business stakeholders and the IT units involved
Define and document the architecture standards, principles, and guidelines for the domain
Ensure that selected software matches your vision for the system landscape by working with project teams during vendor selections and implementation projects
Integrate new demands into the system landscape
Work out the high-level processes with the business stakeholders and define the technical framework conditions with the responsible IT units
Design and plan robust system architectures to support the analytical needs of clinical trials with a focus on systems involved in sample tracking and clinical laboratory operations, such as LIMS and SDMS
5+ years of experience performing architecture design, end to end solution delivery and implementing IT process improvement
Ideally, you are certified in Enterprise Architecture Frameworks (Zachmann, Togaf) or CPSA
Excellent domain knowledge about processes, systems, technologies and interface protocols used in handling and analyzing human samples in the context of a clinical trial
Ideally, you have implemented LIMS, SDMS and sample tracking solutions for a CRO or pharmaceutical company
Strong communication skills especially ability to conceive and articulate the architecture and technical solutions to various kind of (non-technical) stakeholders from different levels within the organization
Strong leadership and mentorship skills, with the ability to provide technical guidance and support to other IT staff in the domain
Knowledge of data integrity, audit trails, and electronic signatures, and experience in implementing and validating regulatory compliance systems
Ideally, you have a firm understanding of regulatory requirements, such as CLIA, CAP, and HIPAA
Knowledge of data modeling and data governance principles
A broad understanding of IT infrastructure related technologies (e.g. cloud, SOA, Containerisation, Citrix), especially in regards of GLP / GCP compliant deployment would be beneficial
Strong analytical and problem-solving skills to identify and prioritize technology needs and opportunities and define quality goals and scenarios for the domain
Fluent in English and good German language skills
Flexible Working Time
Mobile Office
Work from EU Countries (up to 20 days per year)
Company Pension Scheme
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