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For our clients, an international company from the head office in Ireland, we are looking for a person for the position:
Validation EngineerMiejsce pracy: Dublin
The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of coating equipment, processes, and systems.
Key Responsibilities:
- Responsible for Design for Manufacture, ensuring conformance with current equipment, process, and systems validation regulations
- Responsible for determining the implications of validations upon; Product Quality, Patient Safety, and Data Integrity
- Responsible for completing Equipment Lifecycle documentation, URS, FS etc
- Participate in equipment, process, and software development and design review
- Responsible for determining and implementing control measures to reduce the occurrence and possible impact of failures
- Responsible for determining process inputs and factors for variation where process capability is required
- Responsible for calculating process capability
- Maintain, complete and accurate documentary evidence concerning Qualification and Validation exercises
- Responsible for communicating and obtaining input/acceptance of stated exercises by relevant departmental personnel
- Responsible for conducting (where appropriate) Installation, Operating and Performance Qualification (IQ,OQ, PQ)s
- Responsible for validation activities for NPI’s / product transfers
- Responsible for process and equipment risk management pFMEA / RA
- Responsible for implementing/validating new technologies
- Ensure HSE is included on all Quality change order procedure
- All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform
Requirements:
- Degree level qualification in Engineering/Science or Equivalent
- Minimum 5 years post qualification experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry
- Experience in aspects of QA, validation and ISO 13485.
DESIRABLE:
- Six Sigma Black Belt Certified
- Statistical Engineering Qualification
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
