Kelly Services are recruiting for a contract Validation Engineer for a County Offaly based healthcare packaging company. This company is embarking on executing a Master Validation Process Plan for their pouching converting assets to ensure compliance to 11607-2 & ISO 13485 for sterile barrier systems. The Contractor Validation Engineer will be responsible for the development, execution of OQ &PQ Protocols and Reports as per Master Validation Plan.
- Responsible for executing Validation strategies (Validation Plans, Validation Protocols, Validation Reports) for key site Converting Assets (Pouch Machines) in line with current regulatory requirements and site procedures
- Draft OQ & PQ Protocols for Pouch sealing machines to be compliant to 11607-2 & ISO 13485.
- Route Protocols through Clara approvals process
- Draft OQ & PQ Reports for Pouch sealing machines to be compliant to 11607-2 & ISO 13485.
- Route Reports through Clara approvals process
- Initiate and implement change control activities in accordance with site procedures.
- Deliver to predefined deadline set by the Project Manager, to be creative in validation approach to meet deadlines while also ensuring compliance.
- Implement best validation practices
- Required to execute a few validations concurrently.
- Required to provide feedback to project team members in a constructive manner on work presented for review.
- Champion benchmark & implement best practices in validation to the Clara Site.
- Proven track record in validation execution
- Strong technical writing
- 2 + years' experience in validations required, Quality background an advantage
- Strong statistical skills and process capability analysis are required.
- Ability to think logically
- Self-directed and results driven team player with excellent communication skills.
- Ability to operate cross functionally is a must
- Ability to work as part of a team and on own initiative in a constructive manner
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.