GxP Systems Integration Engineer

Allergan

Chicago, Northern (IL, KY)

Hybrid

USD 120,000 - 180,000

Full time

2 days ago

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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.