Validation Engineer (King Of Prussia, PA):

Responsible for supporting validation projects for clients, authoring and executing Validation Lifecycle documents such as Validation Master Plan (VMP), Validation Plan (VP), Compliance, Risk Profile (CRP), User Requirements Specifications (URS), Risk Assessments, Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Commissioning, Installation Qualification, (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Validation (PV) protocols/reports in accordance with corporate procedures.

Perform Validation Periodic Review for various systems including process equipment, computerized systems, and laboratory equipment.

Analyze information and provide solutions based on technical knowledge of the systems; identify and escalate gaps, develop gaps remediation plans, and implement corrective actions.

Draft, revise, and provide technical input with respect to Standard Operating Procedures, Work Instructions, and template development. Maintain validation life cycle documents in Quality Management System (QMS).

Perform equipment risk assessments to assess impact of system functionality, data integrity, and control product quality.

Participate in cross-functional teams to assist with deviations investigations, Corrective & Preventive Actions (CAPA), and change controls in Trackwise.

EDUCATION REQUIRED: Bachelor's Degree in Biosystems Engineering, Biotechnological Engineering, Mechanical Engineering, Civil Engineering or closely related field or foreign equivalent

TRAINING REQUIRED: N/A

EXPERIENCE REQUIRED: 2 years' experience as Validation Engineer

OTHER SPECIAL REQUIREMENTS:

Prior experience with Quality Management System Trackwise and Corrective & Preventive Actions (CAPA) Software

Occasional travel to unanticipated clients' sites locally required.

CONTACT: Submit Application for this role to Laporte Consultants Corp @ career@laporteconsultants.com w/Ref#VE25

Laporte Consultants Corp

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Validation Engineer