Validation Engineer – Steralisation.
What you need to know
You will work as a Validation Engineer for our client, a well-established Medical Device company in Co. Offaly.
Our client helps their customers to create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
In this role the Validation Engineer (EO) collaborates with Customers to ensure their qualification requirements are met or exceeded throughout all stages of the validation. They manage customer Validations and all associated documentation in compliance with the Quality Management System, ISO11135, and ISO13485 regulatory requirements while adhering to GMP and GDP requirement.
This is a Permanent role
Your new job
Key duties & responsibilities:
- Collaborates with Customers throughout all stages of their Validation projects to establish cycle process parameters in line with SEO and in compliance with 11135.
- Coordinates validation cycles, reviews, and approves validation protocols, reports, CSPs etc. within agreed timelines.
- Facilitates Cross functional department and Customer Training requirements.
- 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.
- Collaborates and proactively supports the EO Tech Team Supervisor and EO Tech Team Manager to achieve goals. Identifies opportunities for improvement and implements solutions in line with best practice.
- In partnership with the EO Tech Team Supervisor and Site Quality Manager identifies and implements effective corrective actions to prevent non-compliances and/or reoccurrence of non-conformances.
- Supports introduction of and compliance to Global work instructions, EMEA harmonisation, and initiatives.
- Supports and facilitates departmental, cross functional and Customer training requirements in area of Technical expertise.
- Prepares, supports, and facilitates EO Technical internal audits and external audits conducted by customers, notified bodies and Regulatory Agencies.
- Acts on assigned audit findings and implements effective corrective action.
- Conducts internal audits of the quality management system, documents and reports audit findings and recommendations for improvement.
- Communicates in an effective manner, collaborates with all employees, Customers, auditors, and visitors to the site in a professional, courteous, and respectful manner providing prompt and accurate responses. Encourages the sharing and exchange of ideas and removal of barriers to achieve common goals.
- Aware of Health and Safety requirements, follows safety policies and procedures and promptly reports any risks or observed breaches to the Health and Safety representative.
- Manages their individual training and development, identifies training and development opportunities, maintains professional skills and knowledge by attending training and development sessions.
- Documents and files training records and certifications.
- Maintains professional skills and knowledge by attending education workshops, reviewing professional publications, and taking part in professional forums.
What are we looking for?
- Diploma/Degree in life-science or Engineering with knowledge of cycle development and a working knowledge of sterile lab functions.
- Working knowledge of ISO11135 and ISO13485 process validation and Microbiological/chemical testing desirable.
- In lieu of meeting the minimum educational requirement applicants with a minimum of 8 years industrial experience in EO sterilisation, demonstrating strong technical skills with comprehensive working knowledge of quality standards ISO11135 and ISO13485 process validation and Microbiological/chemical testing associated with the EO sterilisation process will be considered.
Apply for this job now or get in touch with Aoife Mc Loughlin on email@example.com
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