BTS Senior Engineer, Technology I

The Sr. Engineer Technology I enables the full lifecycle of AbbVies 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. 

Qualifications :

Required:

• Bachelors Degree with 6 years relevant experience; Masters 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 

Additional Information :

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time