Validation Engineer

Description

• Deliver the validation site strategy in a safe, compliant manner and to the highest standard of performance.
• Planning, execution and reporting the on-going validation compliance of facilities, equipment, systems and processes at Genzyme Ireland in both solid dosage forms and sterile products manufacturing.
• Right first time execution of re-qualifications, quality reviews, computer systems periodic reviews and to scheduled timeline
• Maintain compliant validation systems/processes on-site, including the maintenance of the site validation master plans.
• Provide validation expertise, technical support and knowledge to site cross functional teams.
• Assessment, review and approval of change controls to maintain validation status.
• Generation, review and approval of validation risk assessments as appropriate.
• Lead/support validation investigations as appropriate using root cause analysis methodologies.
• Actively participate in a positive team environment where support, challenge, empowerment and continuous learning/knowledge exchange is encouraged.
• Preparation and maintenance of departmental metrics to internal and external stakeholders
• Proactive participation & validation representation at key site meetings and regulatory inspections
• Support MWI process and ensure timely closure of Deviations, Events, CAPAs, LCRs & Tasks etc
• Implement continuous improvement initiatives within validation

• Degree in Science, Engineering or related area

• 3-4 years experience working in a Pharma/Biopharma/Healthcare manufacturing environment.

• 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 of industry and regulatory requirements for sterile and non-sterile facilities and processes.
• 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.