Hybrid validation Engineer bei Smart Ims
Smart Ims · Greenville, Vereinigte Staaten Von Amerika · Hybrid
- Professional
- Optionales Büro in Greenville
****** Onsite role *****
Summary
• Provide validation experience and guidance during equipment design, software design, build, debug, and
qualification phases of a project.
• Develop pertinent document templates tailored to customer SOP’s.
• Write overall project quality (validation scope) plans.
• Organize, guide, and write requirement specifications as necessary.
• Organize, guide, and write qualification plans and protocols as necessary.
• Review qualification/requalification packages for completeness and accuracy, sound rationale, compliance
with validation policies.
• Interface with internal and client validation and engineering teams to secure document approvals.
• Oversee and execute validation qualifications at our facility and at the customer’s site.
• Create validation summary reports.
• Drive a quality approach into the organization, change control, and documentation for the equipment
design, software, and documentation.
• Support all aspects of the Validation life cycle, from design through operation and improvement.
Requirements:
- 3+ years performing validation activities.
- Experience in custom engineered solutions, Medical Devices, or Life Sciences is preferred.
- Experience working with electrical design drawings. Proficient in Microsoft Office.
- Experience working in a GAMP 5 based validation model preferred. Excellent presentation skills and ability to mentor without direct authority.
- Ability to work in a team environment.
- Self-starter, able to work with minimal guidance. Experience with Rockwell Automation PLC Control Systems is preferred.
- Experience debugging/working with custom machines is preferred.
Educational experience: Bachelor of Science degree (B.S.) in Systems Engineering, Life Sciences, Electrical/Controls Engineering, or Quality Assurance, related experience or the equivalent of.
Job Description:Additional Information:
All your information will be kept confidential according to EEO guidelines.
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