Job DescriptionThe 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.
Qualifications- 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.
- 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 InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- 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.
