Roles & Responsibilities:

• Provide validation experience and guidance during equipment design, software design, build, debug, and qualification phases of a project.


• Write overall project quality (validation scope) plans. Organize, guide, and write requirement specifications 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.


• Organize, guide, and write qualification plans and protocols as necessary.


• Work through validation documentation in a timely manner to meet project schedules.


• C...