Global Validation Expert
2 weeks ago
We are seeking a skilled Senior Validation Engineer to join our team on a 6-month contract basis. The successful candidate will be responsible for leading the validation activities for a new medical device product at our manufacturing site in Galway.
">Key Responsibilities:
Develop and/or approve validation documentation, including protocols, records, and reports.
Perform and oversee process and test method validation activities within the project.
Collaborate with Operations, Quality Assurance, and R&D teams to execute validation activities.
Ensure timely completion of validation activities and reporting in accordance with the project plan.
Verify compliance with current Good Manufacturing Practices (GMPs) and 21 CFR 820 requirements in all validation aspects.
Communicate with functional groups to ensure awareness of validation requirements.
Investigate and troubleshoot validation problems, determine solutions, and communicate results to management.
Prepare summaries of validation testing for regulatory submissions and present validations to regulatory agencies as required.
Qualifications and Experience:
Bachelor's degree in an engineering, technology, or scientific discipline required with 5+ years' experience in the medical device or pharmaceutical industry.
Prior experience in designing and executing process and test method validations.
Strong analytical skills, exceptional writing, and interpersonal relationship skills or a combination of relevant work experience and education.
Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
Ability to work collaboratively as part of a team and meet targets efficiently.
Excellent organizational, management, and communication skills.
Important Note:
Some details may have been omitted from this job description. This job is open to all qualified applicants, regardless of age, disability, gender identity, marital status, national origin, political belief, pregnancy, race, religion, sex, sexual orientation, veteran status, or any other protected characteristic.
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