Equipment and Process Validation Engineer Job Richmond area,Virginia USA,Quality Assurance

The Validation Engineer will support a facility-wide validation review and remediation initiative within a regulated manufacturing environment.
The consultant will perform periodic reviews of manufacturing equipment, processes, and selected QC laboratory systems to confirm that each system remains in a compliant and validated state.
Responsibilities will include reviewing legacy validation packages, comparing existing documentation against current procedures and risk requirements, conducting gap and risk assessments, identifying deficiencies, and recommending or completing required remediation activities.
The consultant will draft and revise validation plans, protocols, risk assessments, qualification documents, and final reports; execute qualification or validation protocols when required; document discrepancies; and ensure identified gaps are tracked through closure.
The role will primarily involve detailed documentation review and technical writing, with additional responsibility for protocol execution, report preparation, change documentation, and collaboration with Engineering, Manufacturing, Quality, and laboratory personnel.

Job Description

The Validation Engineer will support a facility-wide validation review and remediation initiative within a regulated manufacturing environment.
The consultant will perform periodic reviews of manufacturing equipment, processes, and selected QC laboratory systems to confirm that each system remains in a compliant and validated state.
Responsibilities will include reviewing legacy validation packages, comparing existing documentation against current procedures and risk requirements, conducting gap and risk assessments, identifying deficiencies, and recommending or completing required remediation activities.
The consultant will draft and revise validation plans, protocols, risk assessments, qualification documents, and final reports; execute qualification or validation protocols when required; document discrepancies; and ensure identified gaps are tracked through closure.
The role will primarily involve detailed documentation review and technical writing, with additional responsibility for protocol execution, report preparation, change documentation, and collaboration with Engineering, Manufacturing, Quality, and laboratory personnel.

Primary Responsibilities

Conduct periodic validation reviews for manufacturing equipment, processes, utilities, and selected QC laboratory systems.
Review legacy equipment qualification and process validation documentation for completeness, accuracy, and continued compliance.
Compare existing validation packages against current SOPs, regulatory expectations, and system risk profiles.
Perform gap assessments and risk assessments to identify deficiencies in the current validated state.
Develop remediation plans and complete assigned corrective validation activities.
Draft, revise, and execute IQ, OQ, PQ, process validation, and related qualification protocols as applicable.
Prepare validation plans, risk assessments, protocols, summary reports, and supporting technical documentation.
Review executed protocols for completeness, accuracy, data integrity, deviations, and required follow-up.
Support deviation resolution, change control, management-of-change activities, and documentation updates.
Work with Engineering, Manufacturing, Quality, Automation, and laboratory personnel to collect technical information and resolve documentation gaps.
Maintain organized, inspection-ready documentation within an electronic quality management system.
Manage assigned reviews independently and communicate project status, risks, and obstacles to site leadership.
Complete approximately one comprehensive periodic review or assigned system area per month,…