Software Engineer

📋 Description

• Lead design/implementation of integration solutions for Quality systems (LIMS, QMS, document mgmt)
• Collaborate with Quality, IT, Validation, vendors to define requirements and architectures for
• Optimize and maintain interfaces/APIs for secure, validated data exchanges between quality systems
• Drive software delivery projects: requirements, development, testing, qualification, deployment in
• Develop technical docs, integration specs, workflow diagrams, validation protocols.
• Act as subject matter expert in system integration, mentoring, and guidance during

🎯 Requirements

• Bachelor’s Degree with 5 years’ experience; Master’s with 4 years’ experience
• 5+ years in IT/software engineering with GxP/Quality system integration and validated CS
• Proficiency in REST/SOAP APIs, ETL tools, middleware, ESB; experience with Quality systems in pharma
• Expertise in software validation, GAMP 5, 21 CFR Part 11, risk-based validation, SDLC
• Excellent communication, organization, and cross-functional leadership
• Experience with affiliates, vendors, and stakeholders to gather requirements and ensure delivery

🎁 Benefits

• Medical/dental/vision insurance
• 401(k) plan
• Paid time off
• Short-term incentive programs
• Career development opportunities
• Equal opportunity employer