Validation and Calibration Engineer ensuring equipment reliability and product quality in a pharmaceutical environment. Planning, executing, and maintaining validation and calibration activities in compliance with cGMP regulations.
About the role
- Embedded technical AI specialist onsite with a strategic enterprise client at WRITER. Managing AI platform deployment and building relationships with client stakeholders while navigating complex technical environments.
Responsibilities
- Serve as WRITER's embedded technical AI specialist onsite, building strong daily relationships with client engineering, AI COE, and business teams, and acting as the primary point of contact for all WRITER-related technical matters
- Own the end-to-end release workflow from WRITER platform updates through production deployment across all client environments, including coordinating dual-track updates, making critical go/no-go decisions, and providing hands-on troubleshooting
- Design, implement, and maintain the client's custom front-end setup, production retrieval, and agentic systems, while rigorously testing, validating, and troubleshooting AI-specific features like LLM applications, RAG performance, and prompt engineering
- Navigate client security, risk, and compliance approval processes, working with Information Security teams to obtain necessary approvals, documenting compliance artifacts, and streamlining workflows to meet regulatory requirements
- Reduce operational pain points, contribute to long-term migration strategies for clients towards standard WRITER-managed environments, and gather real-world deployment feedback to strategically influence WRITER's product direction
Requirements
- 7+ years of professional experience in software engineering, with at least 5 years specifically in AI/ML development and 2+ years in highly regulated, customer-facing roles at enterprise scale
- Expert-level proficiency in Python and modern JavaScript (ES6+), production software development, systems design, and modern front-end frameworks (React, Vue.js, Angular)
- Extensive hands-on experience deploying and optimizing LLM-based applications and agentic systems in production environments, with deep knowledge of RAG implementation, CI/CD practices for AI, and evaluating AI model performance
- Proven track record of managing complex multi-environment release pipelines, coordinating synchronization between distributed systems, and expertly navigating enterprise approval workflows and governance in Fortune 500 or large financial services clients
- Demonstrated ability to Connect effectively with diverse client stakeholders through onsite embedding, Challenge existing technical paradigms to drive innovation, and Own problem-solving from discovery to production impact, exhibiting strong analytical, communication, and presentation skills suitable for executive engagement
Benefits
- Generous PTO, plus company holidays
- Medical, dental, and vision coverage for you and your family
- Paid parental leave for all parents (12 weeks)
- Fertility and family planning support
- Early-detection cancer testing through Galleri
- Flexible spending account and dependent FSA options
- Health savings account for eligible plans with company contribution
- Annual work-life stipends for:
- Wellness stipend for gym, massage/chiropractor, personal training, etc.
- Learning and development stipend
- Company-wide off-sites and team off-sites
- Competitive compensation, company stock options and 401k
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