Career Category
Operations
Job Description
Job Title
Software Development Engineer
Job Summary
The Software Development Engineer is responsible for configuring, testing, automating, and supporting digital systems used in regulated manufacturing and enterprise environments. This role supports the full application lifecycle, including configuration, automated testing, release management, and validation activities, with a strong focus on quality, compliance, and operational reliability.
The role works closely with Manufacturing, Quality, Automation, and IT teams to deliver validated, scalable, and audit‑ready digital solutions.
Key Responsibilities
Application Configuration & Lifecycle Support
• Configure and maintain enterprise applications and workflows supporting manufacturing and business operations.
• Implement business rules, validations, conditional logic, and role‑based access aligned with SOPs and compliance requirements.
• Support enhancements, defect remediation, and lifecycle management across development, test, and production environments.
• Participate in standardization and reusable component development to support scalable deployments.
Testing & Robotic Automation
• Design and execute functional, regression, and user acceptance testing (UAT).
• Develop, maintain, and execute robotic / automated test scripts to support regression and repeatable testing.
• Support test automation frameworks and tools used for UI‑based, process‑based, or integration testing.
• Analyze defects, perform root cause analysis, and support resolution and re‑testing activities.
DevOps & Release Management (Copado)
• Support application release management using Copado, including deployments, user stories, test levels, and promotion across environments.
• Collaborate with development and quality teams to ensure controlled, traceable, and compliant releases.
• Support change control, impact assessments, and release documentation aligned with enterprise standards.
• Ensure traceability between requirements, configuration changes, test execution, and releases.
Quality & Compliance
• Ensure systems and solutions comply with GMP/GxP, data integrity, and audit requirements.
• Support validation activities (IQ/OQ/PQ or equivalent), including test execution and evidence collection.
• Participate in deviation investigations, change controls, and periodic reviews.
• Provide system, testing, and release evidence to support internal and external audits.
Collaboration & Support
• Partner with Product Owners, Manufacturing SMEs, Quality, and IT to refine requirements and acceptance criteria.
• Support deployments, post‑deployment validation, and production issue resolution.
• Provide user support, troubleshooting, and system documentation as required.
Required Qualifications
• 5–8 years of relevant experience with enterprise systems in regulated (GxP/GMP) environments.
• Bachelor's or Master's degree in Engineering, Computer Science, Information Systems, or equivalent experience.
• Experience working with enterprise applications in regulated environments.
• Hands‑on experience with testing and test automation (manual and robotic).
• Experience supporting or participating in DevOps / release management processes, preferably using Copado.
• Understanding of validation concepts, audit trails, and data integrity principles.
• Strong documentation and communication skills.
.