Software Engineer

BioSpace; North Chicago (IL); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k) plan

Job summary

AbbVie in North Chicago, IL is seeking a Software Engineer to design and optimize system integrations for Quality, Laboratory, Validation, and Manufacturing IT platforms.

You will lead integration architectures for LIMS, QMS, document management and other GxP systems, ensuring compliant, reliable data exchanges across ERP/MES and cloud/on-prem environments. Strong SDLC and regulatory knowledge (21 CFR Part 11, GAMP 5) are required.

Qualifications

• 5+ years of IT or software engineering experience in GxP/Quality system integration.
• Proficiency in REST/SOAP APIs, ETL tools, middleware and ESB.
• Experience with cloud (AWS/Azure), databases, and data security in regulated environments.
• Software validation, GAMP 5, 21 CFR Part 11, risk-based validation, and SDLC in regulated environments.
• Strong communication and cross-functional leadership skills.

Responsibilities

• Lead design and implementation of integration for Quality systems (LIMS, QMS, document management) enabling data interoperability.
• Collaborate with Quality, IT, Validation, vendors to define requirements and ensure compliance.
• Optimize and maintain interfaces for data exchange between quality systems and ERP/MES/Cloud.
• Drive software delivery projects including requirements, development, testing, qualification, deployment in regulated frameworks.
• Develop technical docs, integration specs, workflow diagrams, and validation protocols.
• Serve as SME for system integration and quality software delivery best practices; mentor others.
• Identify process improvements and new technologies to boost reliability and compliance.
• Engage vendors, review contracts, gather cost estimates, ensure policy compliance.
• Communicate project status, risks, and challenges to stakeholders.

Skills

REST/SOAP APIs

ETL tools

Middleware/ESB

GxP software validation

Cloud security

Education

Bachelor's degree

Master's degree

Tools

AWS

Azure

QMS/LIMS

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

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,LinkedInandTik Tok.

Job Description

TheSoftwareEngineerwill serve as a technical expert independently designing, implementing, andoptimizing system 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 computerizedGxPsystems, 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

• Bachelors Degree with 5years experience;Masters Degreewith 4years experience
• At least 5 years' experience in IT or software engineering, with specific experience inGxP/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

• 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.