Software Engineer

Allergan; Chicago, Northern (IL, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie in Chicago, IL seeks a Software Engineer to design, implement, and optimize system integrations for Quality, Laboratory, Validation, and Manufacturing IT platforms within regulated environments.

You will lead data interoperability across LIMS, QMS, ERP, MES, and cloud/on-premises systems, ensuring compliant delivery, validation, and robust security in accordance with 21 CFR Part 11 and GAMP 5.

Qualifications

• Bachelor's degree with 5+ years or Master's with 4+ years of experience.
• At least 5 years' IT/software engineering experience with GxP/Quality system integration and validated computer systems implementation.
• Proficiency in integration technologies (REST/SOAP APIs, ETL tools, middleware, ESB) with quality systems in pharma.
• Demonstrated expertise in 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 goals, and troubleshoot complex integration issues.
• Experience with cloud (AWS/Azure), databases, and data security in regulated environments.
• Strong documentation and technical writing skills for audit-ready deliverables.
• High initiative and ownership; ability to work independently while mentoring junior team members.

Responsibilities

• Lead design and implementation of integration solutions for Quality systems (LIMS, QMS, document management) enabling seamless data interoperability.
• Collaborate with Quality, IT, Validation, and vendors to define requirements and architectures meeting compliance.
• Optimize and maintain interfaces/APIs for secure data exchanges between quality systems and ERP/MES/cloud/on-premises databases.
• Drive delivery projects including requirements analysis, development, testing, qualification, and deployment in regulated frameworks (21 CFR Part 11, GAMP 5).
• Develop and manage technical documentation, integration specs, workflow diagrams, and validation protocols.
• Serve as subject matter expert for system integration and quality software delivery best practices; assist during audits/inspections.
• Identify and implement process improvements, automation, and new technologies for reliability and compliance.
• Facilitate vendor engagements, review contracts, gather cost estimates, ensure vendor compliance with policies.
• Communicate project status, risks, and updates to stakeholders with clarity.
• Ensure all work aligns with AbbVie policies, GxP guidance, cybersecurity, and SDLC standards.

Skills

REST APIs

SOAP APIs

ETL tools

Middleware/ESB

Cloud (AWS/Azure)

Databases

Data security practices

Software validation

GAMP 5

21 CFR Part 11

SDLC

Regulatory compliance

Regulated environments

Education

Bachelor's Degree

Master's Degree

Tools

AWS

Azure

SQL/NoSQL databases

ETL tools

Middleware/ESB

Job description

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 at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The Software Engineer will serve as a technical expert independently designing, implementing, and optimizing system integrations for Quality systems and GxP-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.

• Lead the design and implementation of integration solutions for Quality systems, including LIMS, QMS, document management, and other computerized GxP systems, 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.
• Optimize and maintain interfaces/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, sharing expertise, mentoring others, and providing technical guidance during audits or inspections.
• Identify and implement process improvements, automation, and new technologies supporting integration reliability and compliance.
• Facilitate vendor 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, GxP guidance, cybersecurity, and software development lifecycle (SDLC) standards.

Qualifications

• Bachelor's Degree with 5 years' experience; Master's Degree with 4 years' experience
• At least 5 years' experience in IT or software engineering, with specific experience in GxP/Quality system integration and validated computer system implementation.
• Proficiency in integration technologies (e.g., REST/SOAP APIs, ETL tools, middleware, ESB) and experience with Quality systems common to the pharmaceutical industry.
• Demonstrated expertise in 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 level of initiative and ownership; ability to work independently while mentoring junior team members.

Additional Information

• 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.

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