Validation Engineer (CSV)
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 with a focus on Computer Systems Validation. The role will be based in the Sanofi Waterford site. The role will support capital projects/equipment qualification and the site Serialisation program. The role will require you to work within the site Validation team but also cross-functionally across site departments. Previous validation experience in Sterile Manufacturing, Solid Dose, Packaging and Devices would be highly advantageous for the role in particular Equipment Validation.
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.
In the Validation Engineer (CSV) role, you will be required to support capital projects/equipment qualification and the site Serialisation program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of equipment, systems and processes at Sanofi Ireland. The following activities will be included as part of your role:
· Designing, executing and reporting on validation studies for 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.).
· Providing technical interpretation and guidance of current US FDA and EU validation requirements for solid dose manufacture, aseptic processing, lyophilisation, sterilisation and depyrogenation.
· 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.
· Relevant Engineering or Science qualification.
· Previous validation experience in Sterile Manufacturing, Solid Dose, Packaging and Devices would be highly advantageous for the role. Experience, qualification and knowledge of Computer Systems Validation is necessary.
What makes this position unique?
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.
Benefits of working in this role
Sanofi is committed to training and development. Due to the cross-functional nature of the validation work you will get exposure to many areas of the business. As part of the role, there will be opportunities to work on validation / CSV activities within Sterile Manufacturing, Solid Oral Dose, Packaging and Devices. There will also be opportunities for both technical and professional development.
What Sanofi can offer you
· A role where you are instrumental to creating best practice and as the organisation grows, you can too.
· 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.
· Leadership opportunity.
· A newly refurbished gym is available onsite.
· You will be based in our Waterford site which is accessible from M9.
· Parking available onsite.
· This is a full time role and we support flexible working.
At Sanofi diversity and inclusion is foundational to how we operate and is embedded in our Core Values. We respect the diversity of our people, their backgrounds and experiences. 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 employees, patients and customers.
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.