About this role
The team is seeking a skilled Software Engineer to join their team. In this role, you will be responsible for developing and executing validation strategies and plans for both new and existing computerized systems. You will play a crucial role in ensuring compliance with industry regulations and standards.
Key Responsibilities:
- Develop and execute validation strategies and plans.
- Create and maintain validation documents including User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, Validation Plans (VP), and IQ/OQ/PQ Protocols and Reports.
- Prepare and maintain Traceability Matrices.
- Ensure compliance with FDA regulations, EMA guidelines, and GAMP 5 standards.
- Collaborate with IT, Quality Assurance, Manufacturing, and other stakeholders to ensure system integrity and compliance.
Required Skills & Qualifications:
- Bachelor's degree in Computer Science, Engineering, or a related field.
- Strong experience in software validation and compliance within regulated environments.
- Familiarity with FDA, EMA, and GAMP 5 standards.
- Proficient in creating and maintaining validation documentation.
- Excellent collaboration and communication skills.
Experience:
- 5-8 years of relevant experience in software engineering and validation.
What we offer:
- An opportunity to work in a dynamic and innovative environment.
- The chance to collaborate with cross-functional teams.
- Professional development and growth opportunities.
Applications are read by our talent team, usually within two working days.
If you look like a fit we will call you, and you will hear from us either way.