Software Engineer

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., 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.

• 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.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
• 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 payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company’s sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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.