Sr Validation Eng
Key Role: Supporting the development and manufacturing efforts of a pioneering medical device company.
We are seeking an accomplished Sr Validation Engineer to cover validation activities for their cutting-edge product. The ideal candidate will possess strong analytical skills, exceptional writing abilities, and excellent interpersonal relationship skills.
* Develop and/or approve validation documentation including protocol records and reports.
* Perform and oversee process and test method validation activities within the project scope.
* Collaborate with Operations Quality Assurance and R&D teams to execute process and test method validation activities.
* Ensure timely completion of all validation activities in accordance with the project plan.
* Maintain compliance with current Good Manufacturing Practices (GMPs) and 21 CFR 820 requirements throughout validation processes.
* Communicate effectively with functional groups to ensure awareness of validation requirements.
* Analyze and troubleshoot validation issues determining solutions as needed.
* Present validation results and progress to management.
* Prepare summaries of validation testing for regulatory submissions when required.
Requirements & Qualifications:
A bachelor's degree in engineering technology or a scientific discipline is required with at least 5+ years' experience in the medical device or pharmaceutical industry.
* Prior experience in designing and executing process and test method validations.
* Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
* Strong analytical writing and interpersonal relationship skills or relevant work experience and education combination.
* Ability to work collaboratively meet targets efficiently.
* Demonstrated organizational management and communication skills.
* Good interpersonal communication skills essential.