3600 Validation Engineer I
Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and the Company corporate principles, quality policies, standards, and core values.
You will work closely with instrument vendors, facilities, IT and lab personnel to coordinate the acquisition, installation, qualification, and periodic review of laboratory instruments.
Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.
Coordinate with laboratory personnel to define qualification requirements.
Author, review and execute equipment qualification protocols.
Coordinate equipment qualification activities with vendors and other support groups.
Coordinate equipment maintenance activities with vendors and other support groups, as required.
Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures
Collaborate and author department policies and procedures.
Sign documents for activities as authorized and described by the Company policies, procedures and job descriptions.
Provide input to technical / investigation reports.
Identify, troubleshoot, and propose resolution to technical problems.
Identify gaps in and potential improvements to systems and procedures.
Receive and provide training.
Provide input to and participate in assay transfer/validation associated with equipment qualification/lifecycle.
Coordinate with customers to support multi-site operational activities.
Present equipment lifecycle and associated procedures/material during internal and external audits and regulatory inspections.
Works to meet schedules and set timelines.
Participate in and/or lead group project teamwork; project and process improvements.
Perform other duties as requested by managers to support Quality activities.