Software Engineer

Software EngineerThe 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.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.QualificationsBachelor's Degree with 5 years' experience; Master's Degree with 4 years' experienceAt 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 InformationThe 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.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 & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: Fraud AlertAbbVie will never request sensitive personal information (such as bank account details, social security numbers, or payment of any kind) during the recruitment process.If you suspect you have received a fraudulent offer or communication claiming to be from AbbVie, please do not respond, open any attachments, or click on any hyperlinks.If you have any questions or concerns regarding the authenticity of a communication alleged to have been made by or on behalf of AbbVie, please contact us immediately.Protect yourself by verifying job offers and communications. Your safety is important to us.NoPay Range: $78500 - 141000 USDWhere We WorkRole is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.