Validation Engineer

Description

This General Validation Engineer role will be part of the Technical Operations Validation team starting up, validating and providing on going technical support to the filling processes at the Vaccines Formulation / Fill facility in Ireland

Key Responsibilities:

Technical Application
- Validation documentation - drafting, reviewing and approving validation documentation.
- Accountable for scheduling, tracking, reporting and achieving project deadlines
- Actively contributing to project teams.
- Co-ordinating the execution of the re-qualification program.
- Information gathering and data analysis
- Performing data analysis and determining conclusions reached.
- Making informed decisions / recommendations around conclusions reached from data analysis.
- A good concept and understanding of Microbiological terminology and principles.
- Reviewing and signing off of data analysis performed by other technical personnel.

Information transfer
- Attending departmental and team meetings focused on qualification / validation activities.
- Serving as a Technical Operation representative for internal technical group discussions.

Compliance
- Understanding and applying industry specific compliance standards / regulations to all Qualification/Validation activities.
- Developing an understanding of the importance, considering impact on GMP and compliance on decisions made.
- Conducting and participating in Risk assessments and root cause analysis.
- Signing off and approving protocols, reports, change controls and deviations.
- Proactively highlighting any issues around compliance.
- Participating in internal and external audits and inspections.
- Continuing learning and self-development
- Willingly accepting challenging assignments
- Proactively keeping up to date with current thinking and best practice
- Seeking developmental projects / opportunities and tasks to improve personal knowledge and capability.

Key Experience:
- Validation experience in vaccine or sterile product manufacturing would be an advantage.
- Experience in IMB/FDA environment advantageous.
- Strong technical writing and communication skills
- Ability to close items to completion.
- Ability to pay high level of detail and QA data to a very high standard.
- Problem solving skills.
- Project Management skills.
- Must be goal-oriented and able to prioritise and manage risks

Education:
- Degree level qualification in Science or Engineering.