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**Job Title:** Process Plant and CQ Lead

**Location:** Pearl River, NY

About the Job

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?

Main Responsibilities:

The Process Plants & CQ Lead is accountable for the management and execution of the following:

+ 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. Applies global engineering guidelines (GEG) and local engineering methods (procedures and standards) for engineering related activities as assigned including:

+ 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

About You

+ 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

Preferred Experience

+ 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

Why Choose Us?

+ Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

+ Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

\#GD-SP

\#LI-SP

\#LI-Onsite

\#vhd

Pursue** **_progress_** **, discover** **_extraordinary_

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

_US and Puerto Rico Residents Only_

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

_North America Applicants Only_

The salary range for this position is:

$73,500.00 - $122,500.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (https://benefits.sanofiusallwell.com/fleet/public/index/ba511bf8-5c32-4828-9861-ab985fffab90/?cid=sanofi) .

Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/)

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)