Process Plant and CQ Lead

Sanofi • Pearl River, NY

70d • $73,500 - $122,500

About The Position

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. The Process Plant & CQ Lead is an engineering quality review and execution support function, responsible for consistent application, governance and maintenance of commissioning and qualification (C&Q) platform procedures, application of C&Q testing templates, engineering standards and specifications on projects (both OPEX and CAPEX). This role will support antigen manufacturing with an emphasis on temperature mapping program management. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Requirements

• Bachelor's Degree is required
• 1-5 years of industry experience. Biotech and Pharmaceutical experience are 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 & 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

Nice To Haves

• Experience with PowerBI, RPA, and real-time analytics
• Participation in digital reliability or automation projects
• Role as Subject Matter Expert (SME) in Commissioning and Qualification
• Proven success in leveraging technology to improve equipment uptime and efficiency

Responsibilities

• Primary C&Q interface with project management and project controls functions for C&Q budget and schedule performance measurements and reporting
• Review and approval of protocols/test scripts, data packs and reports
• Responsible for auditing engineering quality according to site and project level C&Q plans, GEGs and QOQGs on projects
• Responsible for the updates to and approval of site C&Q platform methods and procedures assigned
• Assists technical engineering staff in the use and documentation of the engineering change management process
• Execute initiatives and action items resulting from internal and external audits, change control and deviation remediation
• Position may manage contract associates as required to support C&Q activities and perform other responsibilities as assigned
• Review and approval of engineering impact assessments, protocols and reports to ensure consistent engineering documentation quality, in support of both CAPEX and OPEX project documentation
• Execution of System and Functional Component Criticality Assessments
• Execution of Design Review and Qualification
• Author Protocol/Test Script and Reports as assigned
• Perform Periodic Reviews
• Strong foundation in Commissioning and Qualification

Benefits

• High-quality healthcare
• Prevention and wellness programs
• At least 14 weeks' gender-neutral parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees