Continuous Process Verification (CPV) and Environmental Monitoring (EM) Trending Expert

• Hybrid working
• Location: Budapest

Our Position

The Continuous Process Verification (CPV) and Environmental Monitoring (EM) Trending Expert is responsible for supporting the Global Solution Owner in the implementation, routine management, and optimization of the SPC solution used in manufacturing and quality operations. The objective is to ensure products and process compliance and validation. This role ensures standardized processes, effective data management, data integrity while driving value creation through solution design and deployment—all in accordance with applicable GxP regulations and requirements for pharmaceutical trending.

Context: CPV and EM trendings

CPV process refers to the ongoing monitoring and analysis of critical manufacturing process parameters to ensure consistent product quality over time. It helps identify trends, variations, or potential risks during production, enabling proactive improvements and compliance with regulatory expectations.

EM trending involves the routine collection and analysis of environmental data (e.g., airborne particles, microbial contamination) in cleanrooms or controlled areas to ensure the manufacturing environment remains within specified limits. This is essential to prevent contamination and ensure the safety and quality of pharmaceutical products.

Solution design & test

Support Global Business Solution Owner Deliver User stories / functional specifications in liaison with Digital teams supporting the defined process

Tests & validation: ensure compliance of the solution in defining adequate risk-based validation approach

Build demonstration of the validation status of the solution

Deliver training material, SOPs / Job aids to end users

Solution implementation

Support Global Business Solution Owner in driving effective deployment of the solution

Ensure consistent usage across organizations and adherence to data management rules.

Ensure adequate support to users

Lifecycle Management & Compliance

Ensure compliance throughout solution lifecycle.

Support user community through training and community animation.

Handle changes, trouble shooting and incidents escalation with digital teams and business partners at core solution level in liaison with Global System Owner and Process Owner.

Process Standardization

Contribute to standardization of processes and ways of working.

Coordinate usage consistency across organizations/GBUs aligned with process design and SOPs/job aids

Experience:

• 5+ years of experience in pharmaceutical industry
• Hands-on experience in CPV and EM trendings
• Experience in digital / computerized systems in project mode

• Technical skills:
  • Proven experience in GxP regulated environments
  • Solid knowledge of computer system requirements & validation
  • Experience implementing digital solutions in GxP contexts
  • Ability to communicate, deliver & report
  • Action & result oriented
  • Pronounced appetite for digitalisation & data
  • Trouble shooting & anticipation
• Soft skills:
  • Good communication
  • Results-focused, problem-solving and proactive
  • Action-oriented, results-driven mindset with a focus on customer outcomes
• Education: Technical/scientific education, engineering (life sciences)

• Languages: Good level of Professional English (mandatory ++)

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
• Play an instrumental part in creating best practice within our Procurement Team for Indirects having a great opportunity to be part of a diverse team while you will gain Manufacturing and Supply chain procurement knowledge as well

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#Sanofi #WeNeverSettle #SanofiCareers #PursueProgress #DiscoverExtraordinary #joinsanofi #careerswithpurpose #SBSBUDAPEST #LI-EUR #LI-Hybrid

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!