Lead Validation Engineer - Process & Cleaning
Company: Gables Search Group
Posted on: October 14, 2021
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
- Support validation and requalification activities for process
and cleaning – including work in manufacturing area for collection
of samples, cleaning surface sampling, visual inspection,
- 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
- 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.
- Bachelor’s Degree in a Science or Engineering discipline
- 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%
Keywords: Gables Search Group, Cincinnati , Lead Validation Engineer - Process & Cleaning, Other , Cincinnati, Ohio
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