Lead Validation Engineer - Process & Cleaning
Location Cincinnati, OH
Responsibilities :
The holder of this position is charged with leading validation effort to prove control of the critical aspects of company operations, related to process, cleaning, or other elements.
- Serve as a subject matter expert in process and cleaning validation.
- Support validation and requalification activities for process and cleaning including work in manufacturing area for collection of samples, cleaning surface sampling, visual inspection, etc.
- Author, review, and approve validation documents for systems / projects of varying complexity from approved templates in accordance with approved Standard Operating Procedures.
Review change controls and assess their impact as well as define the required validation activities.
- Understand the science and areas of technical knowledge that underpin area of focus & must be able to apply this knowledge in the development of validation approach and in the presentation, documentation & review of outcome.
- Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed equipment, process, equipment, facility or procedure.
- Assist other areas of the department as needed by applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery.
- Work on cross-functional teams with peers from other technical areas to discuss issues, to develop scientific understanding, and to determine solutions.
Communicate proactively with team members, stakeholders, and management regarding progress, issues, and plans for resolution and to ensure the project team and / or network is fully informed of updates and improvements.
- Determine levels of importance or risk to be assigned to elements under review using scientific rationale to justify scale of effort.
- Understand best industry practice, current developments and opportunities arising for company
- Ensure Validation systems (policies, procedures, reviews, VMPs, etc.) meet current / changing industry demands and that they do so effectively;
the holder of this position is also responsible for the maintenance of these validation systems and ensuring compliance of Validation corrective actions.
Academic / Technical Qualifications :
- Bachelors Degree in a Science or Engineering discipline required
- 5-8+ years relevant validation experience required
- Familiarity with Regulatory requirements and guidance applicable in area(s) of deployment preferred
- Experience working with OSD products preferred
- Must be able to travel up to 10%
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