Software Engineer

• Seeking an experienced software developer with expertise in ASP.NET, web applications, and software development within AWS infrastructure to join our team.
• The ideal candidate will have a strong background in developing and managing multiple web applications and experience working in a regulated industry (preferably pharma or medical devices).
• Additionally, the candidate should have experience with Computer System Validation (CSV) activities and be capable of supporting a CSV Engineer in developing extensive documentation to ensure compliance with regulated industry standards.
• The candidate will be responsible for building and deploying applications using various AWS services such as EC2, S3, Lambda, RDS, and CloudFormation.
• They should be proficient in implementing best practices for AWS cloud infrastructure, including security and scalability.
• The role also requires monitoring and troubleshooting AWS applications to ensure high availability and performance.

Key Responsibilities:
• Develop and manage multiple web applications.
• Utilize web tools to support data analysis efforts in clinical trials.
• Ensure thorough and accurate documentation of all development processes.
• Build and deploy software within AWS environments, including services such as EC2, S3, Lambda, RDS, and CloudFormation.
• Implement best practices for AWS cloud infrastructure, including security, scalability, and cost optimization.
• Monitor and troubleshoot AWS applications to ensure high availability and performance.
• Validate software and perform validation activities.
• Collaborate with Quality, Regulatory, and Computer System Validation (CSV) teams to ensure compliance with industry regulations and standards.
• Contribute to 50% of documentation efforts.

Required Skills and Experience:
• Proficiency in ASP.NET for web application development.
• Strong experience with Python and SQL.
• Proven ability to develop and integrate websites and web applications.
• Extensive experience with AWS development, including EC2, S3, Lambda, RDS, CloudFormation, and other AWS services.
• Familiarity with software validation processes and activities.
• Comfortable with extensive documentation and compliance aspects.
• Experience in the medical device industry or similar regulated environments is a plus.

Qualifications:
• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• Minimum of 5 years of experience in software development.
• Strong attention to detail and excellent documentation skills.
• Ability to work independently and as part of a team.
• Technical expertise with a keen interest in documentation and compliance