QA Validation Engineer at AbbVie · LumiJobs

Responsibilities

Main responsibilities for this role include assigned execution, documentation, and support activities, with guidance from management or senior validation personnel as needed.
Participate in the implementation and maintenance of validation programs and Quality System requirements to meet applicable regulatory and company standards.
Follow approved practices and procedures to help ensure compliance with company policies, cGMP, and applicable regulations for assigned validation activities.
Execute assigned tasks that support the Validation Master Plan and help maintain the validated state of equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, sterilization processes, and laboratory instruments.
Support investigations of validation discrepancies or failures by gathering information, documenting results accurately, and assisting with corrective and preventive actions under supervision.
Participate with plant, engineering, quality, laboratory, and external resources on new installations or system changes to help ensure commissioning and qualification documentation supports cGMP expectations.
Support routine qualifications and requalifications by preparing materials, coordinating assigned activities, executing protocols, and helping ensure completion in a timely manner.
Draft and revise validation-related documents such as protocols, reports, lifecycle documents, user requirements, system classifications, risk assessments, and procedures for review and approval by senior staff or management.
Required and preferred qualifications for this role include education, foundational technical skills, and relevant early-career experience.
Bachelor's degree, preferably in Biology, Chemistry, Engineering, or a related scientific discipline; equivalent relevant experience may be considered where appropriate.
2+ years of overall experience in Manufacturing, Quality, Engineering, Validation, or a related regulated environment preferred.
Good verbal and written communication skills, with the ability to document work clearly and accurately.

QA Validation Engineer

Responsibilities

Benefits

Company

AbbVie

More roles at AbbVie