"Experis, part of the Manpower Group manage all recruitment for Sanofi, Ireland. Sanofi Ireland is situated on a 37 acre site in Waterford. This multi phased Biopharmaceutical facility employs over 600 personnel and is one of Irelands Great Places to work."
On behalf of Sanofi we are recruiting a Validation Engineer to ensure that facilities, equipment, systems and processes are validated in accordance with cGMPs.
- Deliver the validation strategy in a safe, compliant manner and to a high standard of performance.
- Planning, execution and reporting the validation activities of facilities, equipment, systems and processes for Genzyme Ireland.
- Right first time execution of validation activities and to scheduled timeline
- Generation & maintenance of validation project plan(s).
- Generation, review & approval of appropriate validation lifecycle deliverables.
- Provide validation expertise, technical support and knowledge to site cross functional teams.
- Assessment, review and approval of project and site change controls and protocol non-conformances.
- Generation, review and approval of validation & project risk assessments as appropriate.
- Lead/support validation investigations as appropriate using root cause analysis methodologies.
- Actively participate in a positive project team environment where support, challenge, empowerment and continuous learning/knowledge exchange is encouraged.
- Preparation and maintenance of functional project metrics to internal and external stakeholders
- Proactive participation & validation representation at key site meetings, PAI readiness and regulatory inspections as appropriate
- Ensure timely closure of Deviations, Events, CAPAs, change controls & Tasks etc
- Implement continuous improvement initiatives within validation
- Degree in Science, Engineering or related area
- 3-4 years experience working in a Pharma/Biopharma/Med Device/Healthcare manufacturing environment.
Skills & Knowledge
- Competent technical knowledge of facility/utility/equipment/process/cleaning/computer systems validation for solid oral dosage and sterile manufacturing facilities.
- Capable of troubleshooting validation issues associated with projects, process development etc.
- Application of risk-based approach to validation
- Knowledge and ability to provide interpretation and guidance on industry and regulatory requirements
- Understanding of relevant quality and compliance regulations
- Effective project management skills.
- Detailed knowledge of quality management systems.
- Good communication skills at organisation, team and individual levels.
- Ability to use MS Project and SPC packages an advantage
- Understands KPI's for the team and the site.
For more information on this role contact Paul on 01 6455250 or email