BTS Senior Engineer, Technology I

BioSpace; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Health, dental, vision insurance

401(k) plan

Job summary

AbbVie seeks a Sr. Engineer to enable the full lifecycle of AbbVie's Digitalization of Software Life Cycle, from design to evidence collection and inspection readiness.

This role bridges regulation with technology, focusing on governance and automation rather than QA testing. Responsibilities include designing and automating IT controls within CI/CD pipelines, translating regulatory needs for tool configurations, and partnering with Jira, GitHub, JFrog, qTest, and ServiceNow CMDB to ensure live,

Qualifications

• Bachelor's degree with 6 years' relevant experience;Master's with 5 years';PhD with 0 years'
• Demonstrated experience in a regulated industry (pharmaceutical, medical device, or similar)
• Fluency with modern software development toolchains: GitHub, Jira, JFrog Artifactory, qTest, ServiceNow CMDB, and CI/CD platforms
• 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

Responsibilities

• IT controls design, assurance, end-to-end design, implement, maintain, and continuously improve SLC framework across technology systems (GAMP)
• Drive controls automation to collect, validate, and report IT control evidence within CI/CD pipelines
• Leverage AI tooling to enhance control monitoring, trend analysis, and anomaly detection
• Bridge compliance and technology teams translating regulatory requirements for tool configuration and pipelines
• Partner with tool owners to work with Jira, GitHub, JFrog Artifactory, qTest, ServiceNow CMDB; embed controls at source
• Maintain digital traceability linking requirements, controls, design elements, and verification evidence
• Ensure data integrity by design using ALCOA+ and lifecycle controls
• Support audit and inspection readiness with real-time digital records
• Enable governance to surface interdependencies and translate complexity for leadership
• Contribute to Validation 4.0 principles like quality by design and data integrity by design

Skills

Regulated industry experience

DevOps/CI/CD experience

Regulatory translation

Cross-stakeholder communication

Adaptability in fast-paced env

Education

Bachelor's degree with 6 years

Master's degree with 5 years

PhD with 0 years

Tools

GitHub

Jira

JFrog Artifactory

qTest

ServiceNow CMDB

Azure DevOps

AWS CodePipeline

Job description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

TheSr. EngineerTechnologyIenablesthe full lifecycle of AbbVie'sDigitalization of SoftwareLifeCycle from design and implementation through evidence collection, continuous monitoring, and inspection readiness. This is not a software testing or QA engineering role.This bridgesregulationwithtechnology functionsforIT governanceusingmodern 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 repositorieswork, and who uses that fluency to driveregulatoryexpectationthrough intelligent automation. The engineer translates between governance stakeholders and the engineering teams who build andmaintainthe tools.

Responsibilities

• IT controlsdesignassurance end-to-end design, implement,maintain, and continuously improveSLCframework across technology systems and platforms, applying a patient-centric, risk-based approach aligned with GAMP principles.
• Drive controls automationidentifyopportunities 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 thebridgecomplianceandtechnologyteams 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 assurancemethodologyas technology platforms and regulatory expectations change.

Qualifications

Required

• Bachelor's Degree with 6 years' relevant experience;Master's Degreewith 5 years'; PhD with 0 years'
• Demonstrated experienceworkingina regulated industry (pharmaceutical, medical device, or similar)
• Fluency with modern software development toolchains GitHub, Jira,JFrogArtifactory,qTest, ServiceNow CMDB, and/or CI/CD platforms (Azure DevOps, AWSCodePipeline, 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
• Comfortoperatingat the boundary between governance stakeholders and engineering teams able to communicate credibly in both directions
• Ability tolearn andwork in a fast-pacedenvironment

Preferred

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

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company'ssoleandabsolutediscretion unless and until paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html