Data Integrity & Computer System Validation Support

Job Opportunity: Data Integrity & Computer System Validation Support

Location: Origgio, Varese

About the company 

At Sanofi Consumer Healthcare, we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to drive what we believe is the next health revolution: evolving from simply serving consumers, to helping people help themselves - bringing “Health in Your Hands”. 

We are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”. 

Consumers at the heart of everything we do and we want to make a difference where it counts, driving leadership in the categories we play in: Allergy, Digestive Wellness, Pain, Physical & Mental Wellness, and Cough, Cold & Flu. 

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. We aspire to create a work environment where people can thrive, grow, and be at their best every day. We believe in operating with integrity and prioritizing the health and well-being of people and communities where we operate, working towards making a positive impact in the world. 

Are you passionate about ensuring compliance and integrity in computerized systems within the pharmaceutical industry? Do you possess technical expertise in Data Integrity (DI) and Computer System Validation (CSV)? We are seeking a highly skilled individual to join our team as a Data Integrity & Computer System Validation Support in Origgio, Varese.

Responsibilities:

• Report functionally and hierarchically to the Technical Services & ITS Manager, supporting the compliance steering team dedicated to Data Integrity and CSV requirements.

• Contribute to the compliance of relevant computer systems by performing various tasks in the DI and CSV field.

• Verify and map all plant systems and equipment in collaboration with external consultants.

• Assist in maintaining an updated inventory of the site's computerized systems.

• Collaborate with Engineering during the drafting, design, execution, and testing/qualification activities of new plants and computerized systems.

• Support technical and organizational remediation phases on existing systems, collaborating with maintenance departments and the Quality function.

• Coordinate backup and restore tests on all site computer systems in collaboration with the ITS function.

• Represent the technical focus for planning, execution, and documentation of interventions, including inspection visits or regulatory requests.

• Coordinate external consultancy firms for remediation plans' definition and implementation, ensuring adherence to timelines and project costs.

• Support supplier selection and negotiation activities for services and materials.

• Verify the technical documentation delivered by suppliers relating to equipment and computerized systems.

• Identify solutions to adapt production technologies to DI/CSV requirements in collaboration with involved functions.

• Monitor compliance with security measures and develop solutions to strengthen them.

• Participate in pre-commissioning, commissioning, qualification, validation, and start-up activities.

• Develop documentation for Basic Engineering Design Package and contribute to project development.

• Facilitate professional development and technical training of maintenance and production resources.

• Update technical documentation and site validation related to industrial automation orders.

Qualifications:

• Degree in Mechatronics Engineering, Electronics, Automation, Chemistry, Computer Science, or related field.

• 5+ years of experience in the pharmaceutical or consultancy sector in the DI/CSV field.

• Good knowledge of DI and CSV principles.

• Proficiency in Microsoft Office package, AutoCAD (2D/3D), and infrastructure systems.

• Familiarity with project management techniques, GMP, and quality procedures.

• Strong communication, problem-solving, and time management skills.

• Ability to work autonomously and collaborate effectively in a team environment.

• Fluent in English, both spoken and written.

Join our team and contribute to maintaining the highest standards of compliance and integrity in our computerized systems. If you are ready to take on this exciting challenge, apply now!

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, 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!  

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!