Process Plant and CQ Lead
Sanofi
Full-time
Remote friendly (Pearl River, NY)
United States
$73,500 - $122,500 USD yearly
Operations
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Role Summary
Process Plant and CQ Lead responsible for the engineering quality review and execution support for commissioning and qualification (C&Q) across projects, with emphasis on temperature mapping program management in antigen manufacturing.
Responsibilities
- Primary C&Q interface with project management and project controls for budget and schedule performance measurements and reporting
- Review and approval of protocols/test scripts, data packs and reports
- Audit engineering quality according to site and project level C&Q plans, GEGs and QOQGs
- Update and approve site C&Q platform methods and procedures
- Assist technical engineering staff with the engineering change management process
- Execute initiatives from internal and external audits, change control and deviation remediation
- May manage contract associates to support C&Q activities
- Review and approve engineering impact assessments, protocols and reports; apply global (GEG) and local engineering methods
- Execute System and Functional Component Criticality Assessments
- Execute Design Review and Qualification
- Author Protocol/Test Script and Reports as assigned
- Perform Periodic Reviews
- Strong foundation in Commissioning and Qualification
Qualifications
- Bachelor's Degree required
- 1-5 years of industry experience; biotech and pharmaceutical experience preferred
- Familiarity with IoT, digital twins, and smart manufacturing technologies
- Understanding of AI applications in predictive maintenance and asset management
- Ability to lead change management and support digital transformation initiatives
- Digital mindset and soft skills
- Agility in adopting and applying new technologies
- Data-driven problem-solving and decision-making
- Collaborative approach using digital platforms
- Innovation mindset and continuous learning
- Strong communication and data storytelling skills
Skills
- PowerBI, RPA, real-time analytics (preferred)
- Experience as SME in Commissioning and Qualification (preferred)
- Digital reliability or automation project experience (preferred)
- Proven ability to leverage technology to improve equipment uptime and efficiency (preferred)
Education
- Bachelor's Degree (required)