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.
  Additional Information
  All your information will be kept confidential according to EEO guidelines