remote
Automation CSV Lead - Kelly Services
Software Engineer
Lead automation initiatives for a biologics manufacturing campus, driving computer system validation, GxP compliance, and cloud‑based automation frameworks using Python and scripting.
About the role
Key Responsibilities
- Design, develop, and maintain automated validation solutions for manufacturing and laboratory systems.
- Lead the creation and execution of Computer System Validation (CSV) strategies in a GxP environment.
- Collaborate with cross‑functional teams to integrate automation tools with cloud platforms (AWS) and on‑premise infrastructure.
- Establish and enforce best practices for scripting, version control, and continuous integration/continuous deployment (CI/CD) pipelines.
- Mentor junior engineers and provide technical guidance on automation frameworks and regulatory requirements.
Requirements
- 5+ years of experience in automation engineering with a strong focus on CSV and GxP compliance.
- Proficiency in Python and shell scripting for test automation and data processing.
- Hands‑on experience with automation frameworks, CI/CD tools, and cloud services such as AWS.
- Demonstrated ability to lead validation projects and work with quality/regulatory stakeholders.
- Excellent problem‑solving, communication, and leadership skills.