at Charles River Laboratories in Newark, Delaware, United States
Software Developer (C#/.NET)Req ID #: 178851 Location: Newark, DE, US, 19711
For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
• Contribute to the development projects from initiation to completion, including project planning, development, testing and implementation.
• Work with outside software development consultants and vendors as needed.
• Implement all software policies and procedures, including those for regulatory compliance, architecture, security, data backup and archiving, document management and disaster recovery standards.
• Ensure that development work employs proper configuration management and project tracking controls.
• Collaborate with the Quality department to ensure that proper change control procedures and documentation are in place.
• Collaborate with operations to ensure software requirements satisfy the needs of the organization.
• Minimize exposure and risk on project.
• Ensure project documents are complete, current, and stored appropriately.
• Resolve and/or escalate issues in a timely fashion.
• Participate in project review meetings.
• Lead training and / or ensure effective knowledge transfer to those responsible for training of the new solutions such that adoption and value realization is optimized.
• Ensure adherence to pertinent regulatory requirements [FDA guidelines, cGMP 21 CFR Part 11, MHRA, GAMP5 and strict Data Integrity considerations and IQ/OQ/PQ requirements] and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
• Perform all other related duties as assigned.
+ Education: Bachelor’s degree (B.A./B.S.) or equivalent in software development or related discipline.
+ Experience: Two or more years’ experience in software development in a combination of scientific or business domains is preferred. Specific focus in C# (.NET Framework and .NET Core) application development
+ Strong knowledge of and experience with object-oriented programing
+ Ability to write effective unit, integration, and end user automated tests
+ Strong understanding of Agile methodologies and use of Application Lifecycle Management tools
+ + Certification/Licensure: None
+ Scientific application development experience in a GxP regulated environment preferred.Working knowledge of quality systems is preferred