- Location: Waterford.
- Job Type: Full-time, Contract (12 months).
- Salary: €60 p/h
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.
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.
In the Validation Engineer role, you will be required to support capital projects/equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of equipment, systems, and processes at Sanofi Ireland.
Activities 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 dehydrogenation.
- Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times. Computerised Systems compliance would be beneficial.
- Maintaining validation documentation through the validation lifecycle
- Participation in external regulatory inspections
Skills and Knowledge
- Capable of troubleshooting validation issues associated with
projects, process development etc.
- Competent technical knowledge of pharmaceutical plants.
- Knowledge of requirements for of GAMP, ISPE Baseline
- Knowledge of steam and dry heat validation publications
such as AAMI/ANSI, PDA and ISO guidelines.
- Full understanding of relevant quality and compliance
- Able to execute projects to plan.
- Good knowledge of quality management systems.
- Effective facilitator.
- Good communication skills at organisation, team and
- Ability to use MS Project and SPC packages an advantage.
- Understands KPI's for the site.
Simply Apply Now or contact [email protected] for further information.