Software Engineer

ABBVIE; North Chicago (IL); On-site; USD 79,000 - 141,000; Full time

Job summary

AbbVie is seeking a Software Engineer to independently design and optimize system integrations for Quality and GxP-regulated software environments. You will deliver compliant, reliable data flows across Quality, Laboratory, Validation, and Manufacturing IT platforms, driving continuous improvement and technical leadership.

Responsibilities include leading integration design for LIMS, QMS, and document management, collaborating with Quality, IT, validation, and vendors, and ensuring adherence to

Qualifications

• 5+ years IT or software engineering experience, with GxP/Quality system integration and validated computer systems.
• Experience with REST/SOAP APIs, ETL tools, middleware, ESB in regulated contexts.
• SDLC and software validation knowledge for regulated environments (21 CFR Part 11, GAMP 5).
• Strong documentation and cross-functional leadership skills.

Responsibilities

• Lead design and implementation of integration solutions for Quality systems (LIMS, QMS, document management) enabling data interoperability.
• Collaborate with Quality, IT, Validation and vendors to define requirements and architecture that meet compliance needs.
• Optimize and maintain interfaces and APIs for secure, validated data exchanges with ERP, MES, cloud and on‑prem databases.
• Drive software delivery activities including requirements, development, testing, qualification, and deployment under regulated frameworks.
• Create and maintain technical documentation, integration specs, workflow diagrams, and validation protocols.

Education

Bachelor’s Degree with 5 years’ experience

Master’s Degree with 4 years’ experience

Tools

REST/SOAP APIs

ETL tools

Middleware/ESB

Cloud (AWS/Azure)

Data security in regulated environments

Job description

• Compensation: USD 78500 - USD 141000 - yearly

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onX ,Facebook ,Instagram ,YouTube ,LinkedIn andTik Tok .

Job Description

TheSoftwareEngineerwill serve as a technical expert independently designing, implementing, andoptimizingsystem integrations for Quality systems andGxP-regulated computer software delivery. This role focuses on enabling compliant, reliable, and scalable integration solutions across Quality, Laboratory, Validation, and Manufacturing IT platforms. The engineer ensures robust data flows, system interoperability, and adherence to software delivery and regulatory standards supporting quality initiatives. The role requires continuous improvement of integration methods, technical leadership in selecting emerging tools, and alignment with best practices in software validation for regulated environments.

Responsibilities

• Lead the design and implementation of integration solutions for Quality systems, including LIMS, QMS, document management, and other computerized GxPsystems, enabling seamless data interoperability.
• Collaborate with cross-functional teams (Quality, IT, Validation, vendors) to define requirements, develop integration architectures, and ensure solutions meet business needs and compliance expectations.
• Optimizeandmaintaininterfaces/APIs for reliable, secure, and validated data exchanges between quality systems and enterprise platforms (ERP, MES, Cloud, on-premises databases).
• Drive and contribute to computer software delivery projects, including requirements analysis, development, testing, qualification, and deployment activities within regulated frameworks (e.g., 21 CFR Part 11, GAMP 5).
• Develop and manage technical documentation, integration specifications, workflow diagrams, and validation protocols supporting all integration and delivery work.
• Serve as subject matter expert for system integration and quality computer system delivery best practices, sharingexpertise, mentoring others, andprovidingtechnical guidance during audits or inspections.
• Identifyand implement process improvements, automation, andnew technologiessupporting integration reliability and compliance.
• Facilitatevendor engagement for integration solutions, review contracts, gather cost estimates, and ensure partner compliance with AbbVie's Vendor Management policies.
• Communicate project status, challenges, and risks to stakeholders, providing clear and actionable updates.
• Ensure all integration and software delivery work is performed in alignment with AbbVie policies,GxPguidance, cybersecurity, and software development lifecycle (SDLC) standards.

Qualifications

• Bachelor’s Degree with 5years’ experience;Master’s Degreewith 4years’ experience
• At least 5 years' experience in IT or software engineering, with specific experience in GxP/Quality system integration and validated computer system implementation.
• Proficiencyin integration technologies (e.g., REST/SOAP APIs, ETL tools, middleware, ESB) and experience with Quality systems common to the pharmaceutical industry.
• Demonstratedexpertisein software validation, GAMP 5, 21 CFR Part 11, risk-based validation, and SDLC for regulated environments.
• Excellent communication, organizational, and cross-functional leadership skills.
• Experience engaging with affiliates, vendors, and project stakeholders to gather requirements, provide estimates, and ensure successful project delivery.
• Ability to manage multiple priorities, adapt to evolving project goals, and troubleshoot complex integration issues.
• Experience with cloud (AWS/Azure), databases, and data security practices in a regulated environment.
• Strong documentation and technical writing skills for audit-ready deliverables.
• High levelof initiative and ownership; ability to work independently while mentoring junior team members.

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 timeof 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/visioninsurance and 401(k) to eligibleemployees.

This job is eligible to participate in our short-term incentiveprograms.

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 ofcompensation 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.