Staff Validation Engineer

Performance Validation, LLC has provided Commissioning, Qualification and Validation services to the life science industries for over 25 years. PV is an Indiana LLC company with locations in Indiana, Illinois, Michigan and Georgia providing support throughout the US and overseas.

 Performance Validation is seeking a full-time Level I Validation Engineer/Specialist based in Portage, MI. The Level I Validation Engineer/Specialist reports directly to the Division Director or Manager and will be assigned to one or more project teams headed by a Project Leader.

This individual is expected to develop a sound understanding of how to properly implement technical, quality and scientific principals necessary to meet industry and customer requirements. This individual is expected to work in a team environment to meet defined objectives based on an established timelines.  

• Self-starter who exhibits a professional demeanor, enthusiasm, and ability to work independently with minimal supervision.
  
• Strong interpersonal skills. Must interact confidently with clients, other contractors, and employees.
  
• Possess excellent oral and written communication skills and high attention to detail
  
• Experience with office word-processing and spreadsheet programs such as Microsoft Word and Excel
  
• Depending on assignment, skills may require working knowledge of thermal mapping equipment, computer systems and software, or principals of a specific scientific / technical discipline.
  

• Perform validation and commissioning activities including: Receipt Verification, Installation Qualification; Operational Qualification; Performance Qualification; Requalification; Laboratory Qualification; Methods Validation; Process Validation; Computer system Validation; Aseptic Validation; Cleaning Validation.
  
• Support cGMP programs including: Preventive Maintenance and Calibration. Writing Standard Operation Procedures.
  
• Learn and apply principles of operation of new equipment/ instrumentation/ methodology/ processes and their associated controls; Identify critical parameters affecting quality or safety; and relate those critical equipment parameters to the overall process, including associated specifications, drawings, and technical documentation and performing walk downs, which may include climbing stairs, climbing on equipment, moderate lifting and walking.
  
• Assist in the development of practical methods for inspecting or testing compliance of critical parameters and developing the appropriate procedural steps for performing those tests and inspections.
  
• Assist in the development of concise acceptance criteria for an operational test or inspection. Reviewing data to determine compliance with acceptance criteria.
  
• Apply good documentation practices in execution of protocols, procedures, and other cGMP documents.
  
• Assist in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements. Assist with corrective actions.