Manufacturing Validation Engineer

7 days ago

Limerick, Limerick, Ireland beBee Careers Full time
Job Title: Manufacturing Validation Engineer

Description:

The role of the Manufacturing Validation Engineer is to develop and execute test method validations for test equipment per current QMS/Regulatory standards. This involves validating and implementing medical device manufacturing processes as assigned, identifying equipment/fixture installation qualification requirements, characterizing processes and their outputs/acceptance criteria, preparing written validation reports that meet regulatory/company standards, verifying testing, project management, and maintaining accurate and timely records.

Responsibilities:

- Develop and execute test method validations for test equipment per current QMS/Regulatory standards.
- Validate and implement medical device manufacturing processes as assigned.
- Identify equipment/fixture installation qualification requirements.
- Characterize processes and their outputs/acceptance criteria.
- Prepare written validation reports that meet regulatory/company standards.
- Verify testing.
- Manage projects effectively.
- Maintain accurate and timely records.

Qualifications:

To be successful in this role, you will need a Bachelor's degree in Engineering or a related field, with a minimum of 3 years' experience in validation/relevant fields. You must have strong interpersonal and organizational skills, excellent communication skills at all levels of the organization, and the ability to communicate complex ideas clearly. Additionally, you should be willing to seek out and drive improvement, have proven project planning skills, and be able to execute projects in a timely and effective manner. Teamwork and problem-solving skills are essential, along with the ability to work in a fast-paced environment with attention to detail.

Benefits:

This role offers a range of benefits, including a hybrid work model, company-sponsored pension scheme, medical health insurance cover for you and your immediate family, life assurance, income protection cover, educational assistance, performance-related bonuses, an extensive health and wellness program, and much more.

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