Software Engineer at AbbVie · LumiJobs

Responsibilities

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.
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.

Software Engineer

Responsibilities

Benefits

Company

AbbVie

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