The Sr. Engineer Technology I enables the full lifecycle of AbbVie'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 expectation through intelligent automation. The engineer translates between governance stakeholders and the engineering teams who build and maintain the tools.
Responsibilities:
- 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 toolchains; 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, GitHub, JFrog, qTest, ServiceNow, 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.
Required:
- 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 toolchains — GitHub, Jira, JFrog Artifactory, qTest, ServiceNow CMDB, and/or CI/CD platforms (Azure DevOps, AWS CodePipeline, or equivalent)
- Ability to translate regulatory requirements into technical specifications, acceptance criteria, and control configurations
- Experience embedding controls into DevOps 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
Preferred:
- Familiarity with AI systems in a regulated context — including governance, validation, and data integrity considerations — is a plus
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- 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 this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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