Senior Developer

Job Description

Highly skilled .Net Core, PLP(Biovia Pipeline Pilot) and Oracle Developer to support the development and maintenance of AAEM, a GMP-validated customized solution used across global manufacturing sites. The ideal candidate will have strong .Net Core expertise, Oracle database modeling skills, Biovia Pipeline Pilot knowledge and ensuring data quality and compliance for Training, Personnel Monitoring and Elapsed Time verification. - Support transition from AAEM solution to new REMS AWS Cloud solution for all AAEM functionalities. - Design, develop, maintain and support AAEM Stage and Production environments. - Build and optimize data models for Oracle to support AAEM modules. - Use Postman to test and validate API endpoints for data integration and automation with site security systems. - Expertise with Braxos software (middleware software for site security systems) - Support and develop .Net Core logic using data from core solutions like MODA, PLA Training and site security systems. Perform unit testing and debugging. - Support Windows scheduled jobs - Support GRW connection, transition to snowflake, PLA-training integrations - Support business compliance requirements avoiding CAPA?s, avoid downtime for business - Support code migration across environments and maintain version control using GitHub. - Collaborate with database administrators and AAEM support teams to resolve data access and performance issues and to support production deployments, security updates and Oracle procedures. - Collaborate with cross-functional teams using Agile/SCRUM methodologies. - Participate in Agile development cycles and contribute to validation documentation (e.g., GRC plans, SOPs, design specs) - Ensure compliance with GMP and other regulatory standards in software development. - Develop, refine test cases aligned with user stories and system specifications in HP ALM/QC - Document technical and functional specifications - Ability to interpret manufacturing business processes and support modules such as: -MODA Personnel Monitoring check and reporting -Operator Elapsed Time in Aseptic Areas -Auto Access Management -Training Reports -eLogBook -Block Access when no entrances for more than 3 months in Grade B area -Real-time Personnel Monitoring check by leaving Grade B area - Develop, refine, and execute test cases aligned with user stories and system specifications. - Perform formal verification and validation activities across AAEM modules, including regression and scenario testing. - Ensure traceability between requirements, test cases, and executed results. - Validate AAEM enhancements, bug fixes, site deployments for accuracy and compliance. - Review and approve test cases routed via HP ALM/QC ensuring alignment with validation protocols. - Document defects, deviations and resolutions in alignment with SOPs and change control processes. - 10+ years of experience in .NET Core, Oracle and ETL development, preferably in regulated environments. - Expert level Hands-on experience with Biovia Pipeline Pilot, including protocol design, parameter configuration, and error handling. - Strong SQL skills and experience with Oracle, SQL Server, PostgreSQL and flat file (csv-files). - Familiarity with HTML, JavaScript, and CSS for UI enhancements. - Tools: Visual Studio, VS Code, Postman, JIRA, GitHub, Toad, DBeaver, HP ALM/QC - Expertise with Braxos software (middleware software for site security systems) - Testing & Security: Unit/Integration Testing - Validation & Compliance: Familiarity with GMP environments, SOPs, GRC processes, audit trail management and validation documentation - Excellent communication and collaboration skills, with the ability to work across global teams. - Experience in GMP validation of customized applications. - Experience on using HP ALM/QC, PDOCS, Databases like Oracle, SQL Server, PostgreSQL - Familiarity with AAEM modules and technologies (MODA, PLA Training, Site Security systems) - Strong understanding of GxP, CSV, and regulatory standards. Aseptic Area Entrance Management (AAEM) is a Digital Quality Core GMP-validated solution that manages and monitor entry into Aseptic Production Areas (APA) and Restricted areas at PGS manufacturing sites. It compares data from different systems (MODA, PLA Training, Site Security Systems, GRW (HR-information)) using site configured requirements by running automated comparisons and report discrepancies, site can focus on corrective/preventative actions and elimination of manual comparison. AAEM is comprised of different components that improve training adherence (100% training compliance), regulatory compliance, automation of security access provisioning for restricted areas, aseptic practices, data quality and data visibility, time saving and cost saving/avoidance, drive standardization. 1.Auto-Access Management 2.Operator in Area Elapsed Time 3.Personnel Monitoring check and reporting 4.Training Reports 5.eLogBook 6.Block Access when no entrances for more than 3 months in Grade B area 7.Real-time Personnel Monitoring check by leaving Grade B area New name will be REMS (Restricted Entrance Management System), rebranding of AAEM application. REMS will be on modern AWS technologies and covering all existing functionality of AAEM. Technologies Used Frontend: .NET Core Backend: .NET Core, Web API, Windows Services, BRAXOS ETL & Data Access: Pipeline Pilot (PLP), MODA integrations, Site Security Systems (S2 + Siport) integrations, PLA Training information, GRW-data Databases: Oracle 19C, SQL Server, PostgreSQL