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ESQlabs GmbH

Principal Platform Engineer, Regulated AI Infrastructure (m/f/d)

Posted 7 days ago
5-10 years experience
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AI Summary

Own the secure, reproducible scientific compute platform, including immutable toolchains, per-run audit trails, workflow execution, evaluation pipelines, tenant isolation, usage metering, and signed provenance. Define and implement technical controls for regulated operations and AI oversight, while setting platform engineering standards and supporting both hosted and client-tenant deployments.

ESQlabs is an innovative, internationally active Contract Research Organization (CRO) and a global leader in the development and application of the Open Systems Pharmacology (OSP) Suite. We combine mechanistic modeling, Physiologically Based Pharmacokinetics (PBPK) and Quantitative Systems Pharmacology (QSP), with software and training to support Model-Informed Drug Development (MIDD) and Next-Generation Risk Assessment (NGRA) for pharmaceutical, chemical, and academic partners worldwide. Our mission is to empower life sciences: helping scientists understand mechanisms of disease and chemical toxicity to optimize individualized, safer, and more efficient treatment and testing strategies.

We are now building an agentic AI framework on top of our open-source products: a platform in which AI agents orchestrate the OSP Suite and our other open-source tools to run regulated modeling workflows end to end.

About the role

As Principal Platform Engineer, you will own the infrastructure that makes our scientific compute qualifiable: reproducible execution, immutable versioning, complete audit trails, provenance that travels with every result, usage metering, and tenant isolation.

You will work closely with our Quality Manager and our scientific leads, and as a peer of our agentic engineering lead. You own the technical controls of ISO/IEC 27001 and the logging and human oversight controls of ISO/IEC 42001, inside a management system owned by the Quality Manager. No pharmacology background is necessary, but you need to have built systems where reproducibility and auditability were requirements rather than aspirations.

Key Responsibilities

  • Make the scientific compute core deterministic and reproducible: pinned and immutably versioned R, Python, and solver toolchains, content-hashed engine versions, and a test suite that proves reproducibility across infrastructure changes.

  • Build the per-run audit trail covering inputs, engine version, model version, parameters, outputs, and timestamps.

  • Expose the compute core as a secure internal API, and build the thin adapter layer that presents it to AI systems.

  • Build the workflow runtime that executes our procedures as code.

  • Generate request schemas, validators, and constraints from a single source of truth.

  • Run the evaluation pipeline in continuous integration: conformance tests against reference case sets, re-execution tests and regression tests, with results stored per procedure version.

  • Instrument usage metering and signed provenance at the tool boundary, so that both are invariant to how a client reaches us.

  • Implement tenant isolation, and enforce authorization, parameter validation, and scope refusal at the tool boundary.

  • Support deployment both inside a client tenant and in a hosted environment, and own the operational difference between the two.

  • Define the qualification unit and the re-qualification trigger policy, and make the technical controls behind 21 CFR Part 11 and EU GMP Annex 11 concrete. Implement the logging and human oversight controls that ISO/IEC 42001 and ISO/IEC 27001 require.

  • Set and evolve the engineering standards for the platform team, covering areas such as supply chain integrity, infrastructure as code, and observability, with the freedom to choose the right tools.


What you bring

  • At least five years of platform, infrastructure, or backend engineering experience, including senior technical ownership of a production system.

  • Demonstrable experience with reproducible builds and execution: dependency pinning, artefact hashing, immutable versioning, supply chain integrity.

  • Strong Python. Comfort working around R and scientific computing toolchains, even if you have not written R yourself.

  • Containerization and infrastructure as code, and the operational maturity to run the same system in a client environment and in your own.

  • API design experience where the schema was a contract with external consumers, including versioning and deprecation in practice.

  • Experience with workflow engines or directed acyclic graph runtimes, and with tool-calling systems for AI agents.

  • Practical security engineering: multi-tenant isolation, secrets management, authorization models. Awareness of the risks specific to LLM-driven systems is a strong plus. Experience implementing ISO/IEC 27001 technical controls is a plus.

  • Exposure to a regulated environment (GxP, 21 CFR Part 11, EU GMP Annex 11, or an equivalent such as medical device software) is valuable. If you do not have it, you should be genuinely interested in acquiring it, because you will be working alongside quality assurance daily.

  • Fluency in English (written and spoken).

  • The ability to work independently in a fully remote, cross-cultural team.

  • No PhD and no pharmaceutical background required.

What's in store for you

The dynamic team behind ESQlabs unites people with different backgrounds, spanning disciplines like pharmaceutical sciences, physics, bioinformatics, mathematics, data science, and software engineering. Our trust in each other, our open-mindedness, and our constant quest for excellence and innovation unite us. We value flat hierarchies, where everyone can contribute ideas and expertise to develop the best product. We are passionate, always willing to broaden our horizons, and love our start-up culture.

You will also benefit from:

  • Flexible work hours and a home office policy that focuses on people and not on numbers

  • An attractive remuneration package

  • Regular in-person team gatherings at locations across Europe.

  • A clearly defined technical problem with a commercial consequence, and the authority to solve it properly rather than quickly.

  • A working environment in which your contribution will make a difference, and that allows you to take ownership of projects and processes

  • Responsibility, autonomy, participation, and career perspective

About us

We collaborate with global corporations in the pharma and chemical industry, as well as start-ups in the life-science technology sector and academic and non-profit research institutions. We define new standards in pharmacometrics and systems pharmacology and toxicology areas. Our software and model platforms help scientists understand mechanisms of diseases and chemical toxicity to optimize individualized treatment of patients and protect the health of the animal and human life.

ESQlabs has attracted international players as sponsors for the OSP Software development. In addition, funding through national and EU-wide research grants allows us to develop our core technologies continuously.

For more information about our culture, values and benefits visit our Unique career opportunities - esqLABS GmbH. 

ESQlabs is an equal-opportunity employer. We welcome applications from all qualified candidates regardless of background, and value the diversity of perspectives this brings to our team.

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