Validation Engineer

PerfVal Labs, Inc.•Raleigh, NC

About The Position

Performance Validation is seeking a full-time Level 2 Validation Engineer/Specialist to join our team in Raleigh, NC The Level II Validation Engineer/Specialist reports directly to the Site Manager and will be assigned to one or more project teams headed by a Project Leader.

Requirements

BS/BA degree and 1-2 years in pharmaceutical or other regulated industry experience directly related to pharmaceutical validation
BS degrees in Biomedical Engineering, Chemical Engineering or Mechanical Engineering preferred
Change and Deviation Management
Strong interpersonal skills. Must interact confidently with clients, other contractors, and employees
Possess excellent oral and written communication skills and high attention to detail
Cleaning, Sterlization, and Decontamination Validation experienced preferred
Device Assembly and Packing experience preferred

Nice To Haves

Cleaning, Sterlization, and Decontamination Validation experienced preferred
Device Assembly and Packing experience preferred

Responsibilities

Develop a sound understanding of how to properly implement technical, quality, and scientific principals necessary to meet industry and customer requirements
Work in a team environment to meet defined objectives based on established timelines
Develop verification/qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports
Execute test protocols, including identification and resolution of non-conformances/deviations
Track and manage change control activities for multiple concurrent projects