Description
I have a fantastic opening for a Validation (Sterilisation) Engineer position I have open with leading medical device company based in Waterford. This is a permanent position and a great opportunity to join a rapidly growing company.QUALIFICATIONS/TRAINING
- 3rd level qualification in Science, Engineering or Quality
- Strong analytical skills with good knowledge of process control systems.
- Knowledge of Six Sigma and Lean tools
- Self-motivated with ability to lead a core team to meet the above objective.
- Decisive, good communicators, self-motivated, have record of achievement and are a good team member.
EXPERIENCE
- 3+ years' experience in Healthcare
- Validation experience for sterilisation is a necessity for this role
- Must be familiar with the regulatory requirements of the FDA and/or ISO.
- Medical device or pharmaceutical environment.
- CGMP
- Documentation control and management
KEY ACTIVITIES/RESPONSIBILITIES
- Preparation and update of Validation strategy docs for sterilisation,
- Preparation and update of validation documentation for sterilisation,
- Execution of annual sterilisation validation programme,
- Continuous improvement of the sterilisation process,
- Management of sterilisation changes,
- Preparation and update of applicable PFMEA's
- Control of equipment and product during validation,
- Raise and follow through on CAPA's and NC's resulting from sterilisation issues,
- Work in partnership with facilities and operations to ensure the smooth running of the sterilisation process.
- Temperature mapping of required equipment
- Project support
- Continuous Improvement activities
- The Quality Systems Manager will specify additional requirements of the job.
If you are interested in this excellent opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.