The Sr. Validation Engineer will be responsible for providing validation guidance and/or direction for the site as well as writing and executing validations for key projects. The position reports into the Validation Lead. This role will be a key interface between Validation, Manufacturing, Quality and Engineering and will support the validation efforts to maintain the site in a compliant state.
Product maintained in a constant state of validation. Meet established validation and revalidation milestones according to approved validation plans. No critical/major observations during audits/inspections, products maintained in constant state of validation. Transfers/launches implemented on schedule and on target without validation related issues. Deviation rates.
- Company Name
- Huntington, WV
Bachelors in Scientific Discipline (Mechanical, Electrical, Chemical Engineering) or 5+ Year of experience in validation and manufacturing science. Excellent local site language and English Experience in the regulated industry with manufacturing processes & related equipment, validation or technical process development. Ability to multitask, and manage parallel path project with resources constraint while maintaining timeline. Established experience with: Product development, Design Controls, Design Review Pre-Validation activities (e.g. Process Development & Characterization) and linkage to Process Validation and Process Control. Validation (Process/Equipment/Computerized Systems/Cleaning) Test Method development and validation Working knowledge of Minitab Able to solve very complex problems that require creativity Proficient at influencing subordinates, peers, and senior management Self-directed Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authority. Fundamental understanding of standard analytical testing.
- How to Apply