Validation Engineer

Job description

Validation Engineer 

About the Opportunity

Sanofi is a leading global healthcare company with a passion for meeting patients’ needs, a diverse dynamic working environment committed to their employee’s development and wellbeing. The position being advertised is an exciting and challenging Validation Engineer role in the Sanofi Waterford site.

The Validation Engineer role will lead and execute the qualification of new processes (Fill Finish new product introductions), equipment and systems at Sanofi Waterford. The Validation Engineer will also support the site requalification program.

The role will require you to work within the site Validation team but also cross-functionally across site departments. Previous validation experience and experience in sterile manufacturing and lyophilisation would be highly advantageous for the role, in particular Process Performance Qualification (PPQ/PV) of Lyo products.

About Sanofi Business Unit

The multiple national award-winning Sanofi Waterford biopharmaceutical and medical device campus is located in Waterford on Ireland’s southeast coast. Established in 2001 and now with more than 700 employees, the site has seen more than €600m invested in state-of-the-art infrastructure and technology. Diversification continues to bring new products to Waterford and the expanded site portfolio continues to create new opportunities.

Key responsibilities

In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes at Sanofi Ireland. The following activities will be included as part of your role:

·  Designing, executing and reporting on Fill Finish Process Performance Qualifications
·   Validation studies for new/existing equipment, systems and processes
·  Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
·  Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
·  Maintaining validation documentation through the validation lifecycle
·  Participation in external regulatory inspections

About You

To excel in this role you will need to have:

·  Relevant Engineering or Science qualification
·  Experience with qualification of equipment and systems and/or processes
·  A minimum of 2 years’ experience in pharmaceutical industry 

What Sanofi can offer you

·  You will have the opportunity to work in an energetic friendly team where team-work is essential.
·  Due to the diverse of the site and the validation work, you will get exposure to many areas of the business with the chance to grow your career and develop your technical and professional skills
·  Sanofi is committed to training and development
·  We offer a generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.  

The values we are live by are teamwork, courage, respect and integrity

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.