Our client a provider of sterilisation services to many of the world’s largest medical device manufacturers is currently seeking a Validation Engineer to manage customer validations and all associated documentation in compliance with the company’s Quality Management system.
You will report directly to the Validation Supervisor and work with them proactively to ensure that validation processes are followed and that customer requirements are consistently met.
This is a permanent role with an excellent salary and package.
Your new job
Key duties & responsibilities include:
- Liaise with customers throughout all stages of their Validation projects to establish cycle process parameters in compliance with ISO 11135.
- Coordinates validation cycles, review, and approve validation protocols, reports, and CSPs, within agreed timelines.
- Liaises with quality, operations, planning, laboratory, and customer service to coordinate and progress Customer validations and projects from initiation to completion.
- Schedules, documents, and coordinates commissioning and recommissioning of sterilisation chambers.
- Identify opportunities for improvement and implement solutions in line with best practices.
- In partnership with the Validation Supervisor and Site Quality Manager identify and implement effective corrective actions to prevent non-compliance and/or reoccurrence of non-conformances.
- Supports and facilitates departmental, cross-functional, and customer training requirements in areas of technical expertise.
- Conducts internal audits of the quality management system, documents and reports audit findings and recommendations for improvement.
- Oversees and assists with the launching, downloading, analysis, verification, and calibration of data loggers. Coordinates the calibration and maintenance of process-related equipment to ensure calibration is maintained within date and equipment operates as intended.
What are we looking for?
- Diploma/Degree in Science or Engineering with a minimum of 1 year of industrial experience.
- Working knowledge of ISO11135 and ISO13485 process validation and Microbiological/chemical testing is desirable.
- Customer Focused, must demonstrate a “Customer first and always” mindset and a passion for serving each Customer.
- A team player who builds constructive and effective relationships.
- Strong communicator (oral and written) who communicate in a clear, concise manner and can clearly express opinions and ideas while maintaining trust and credibility.
- Shows initiative and is a self-starter that takes charge with little direction, seeks clarification if unsure of direction, and voices ideas and opinions.
- Strong organisational skills with the ability to prioritise and complete tasks within designated timelines.
Apply for this job now with a Word version of your CV or get in touch with Oliver at email@example.com
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