Validation Engineer

Description:

• Become familiar with the user, functional, installation, operation and performance requirements for assigned projects and tasks

• Review requirements and source documentation P&IDs, RDs, URSs, SOPs, Specifications), for use in development of equipment commissioning and validation documents

• Support Validation Master Plan development

• Execution of equipment validation protocols (including use of Kaye Validator/temperature monitoring for autoclaves, SIP Systems, washer COP, CIP, FITs, etc.)

• Support Equipment Validation Report development, including drafting documents, managing review cycles and protocol approval

• Preparation and processing of turnover packaging and validation documentation in EDMQ (electronic document management system)

• Provide support for generation, resolution and closure of Equipment Validation related deviations and required documentation

• Assist with coordination of activities between Client teams (validation, engineering, manufacturing, QC, etc.)

• Support resolution of engineering/validation issues found during equipment validation

• Attending meetings as required to support equipment installation and operation

• Providing quality oversight and approval for validation documents as needed

• Support developing SOP’s

Qualifications:

• 3-5 Years of Equipment Validation experience working within a cGMP & FDA Regulated environment

• Previous experience with CQV activities for equipment outlined above

• Supporting engineer will be resident at the Client facility or a previously agreed upon location (i.e. vendor’s location)

• Support to be performed as required by the project schedules