BTS Senior Engineer, Technology

Job Description

The Sr. Engineer Technology enables the full lifecycle of Abb Vie's Digitalization of Software Life Cycle— from design and implementation through evidence collection, continuous monitoring, and inspection readiness. This is not a software testing or QA engineering role. This bridges regulation with technology functions for IT governance using modern tooling.

This role calls for a quality and compliance professional who is deeply technology‑aligned—someone fluent in how CI/CD pipelines, source control platforms, test management systems, and artifact repositories work, and who uses that fluency to drive regulatory expectations through intelligent automation. The engineer translates between governance stakeholders and the engineering teams who build and maintain the tools.

• IT controls design assurance end‑to‑end
  — design, implement, maintain, and continuously improve SLC framework across technology systems and platforms, applying a patient‑centric, risk‑based approach aligned with GAMP® principles.
• Drive controls automation
  — identify opportunities to automate the collection, validation, and reporting of IT control evidence within CI/CD pipelines and integrated tool chains; embrace automation and electronic means over paper‑based evidence, consistent with FDA/industry CSA guidance.
• Leverage AI
  — apply AI tooling to enhance control monitoring, trend analysis, and anomaly detection across regulated systems; understand the compliance and data integrity implications of self‑learning systems and govern them accordingly.
• Serve as the bridge compliance and technology teams
  — translate between governance and regulatory requirements and the engineering teams responsible for tool configuration and pipeline design.
• Partner with tool owners
  — work directly with teams operating Jira, Git Hub, JFrog, qTest, Service Now, and related platforms; embed controls at the source and ensure those tools produce the right evidence in the right form.
• Maintain digital traceability
  — own digital traceability records linking requirements, controls, system design elements, and verification evidence; ensure records are live, dynamic, and continuously audit‑ready rather than static or paper‑based.
• Ensure data integrity by design
  — apply ALCOA+ principles and data lifecycle controls across all governed systems.
• Support audit and inspection readiness
  — lead evidence preparation and coordinate remediation; ensure the team can respond confidently to regulatory inquiries supported by real‑time, digital records.
• Enable governance stakeholders
  — surface interdependencies, communicate control status, and translate technical complexity into compliance‑relevant language for leadership and governance audiences.
• Contribute to continuous improvement
  — support Validation 4.0 principles including quality by design, data integrity by design, and integrated environments; help evolve the controls assurance methodology as technology platforms and regulatory expectations change.

• Bachelor's Degree with 6 years' relevant experience;
  Master's Degree with 5 years;
  PhD with 0 years.
• Demonstrated experience working in a regulated industry (pharmaceutical, medical device, or similar).
• Fluency with modern software development tool chains—Git Hub, Jira, JFrog Artifactory, qTest, Service Now CMDB, and/or CI/CD platforms (Azure Dev Ops, AWS Code Pipeline, or equivalent).
• Ability to translate regulatory requirements into technical specifications, acceptance criteria, and control configurations.
• Experience embedding controls into Dev Ops workflows or software delivery pipelines.
• Comfort operating at the boundary between governance stakeholders and engineering teams—able to communicate credibly in both directions.
• Ability to learn and work in a fast‑paced environment.

• Familiarity with AI systems in a regulated context— including governance, validation, and data integrity considerations— is a plus.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for…