Manufacturing and Supply
Wo Wunder der Wissenschaft
für Patient*innen Realität werden

Job Title: Process Plant and CQ Lead

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.