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Validation Engineer III

Townsend & Associates • McPherson, KS

Posted 11 days ago

Job Snapshot

Travel - None
Experience - 4 to 8 years
Degree - 4 Year Degree
Compensation based on experience
Manufacturing, Pharmaceutical, Other Great Industries
Engineering, Pharmaceutical, Other
Relocation - No


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Job Description

Validation Engineer III
The additional resources are requested to support Winter Shutdown changes. Hours can involve weekend or night shifts. Validation activities including writing system impact assessments, oversight of engineering during shutdown activities, execution of installation qualification, operational qualification, performance qualification, and summarizing qualification results/drafting qualification report summaries. The support staff must act in accordance with plant safety requirements, training and procedures.
  • Schedule and execute validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines.
  • Coordinate and communicate all testing with affected functional groups and evaluates test results.
  • Execute equipment, facility, utility and computer system, Automated Process Control validation studies to include protocol preparation, scheduling, protocol execution, analyze data and compose a final report.
  • Oversee and assist Engineers and/or Technicians with their assigned projects.
  • Provide technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGXP, CFR 21 Parts, 11, 210 and 211, EU Annex 11, ICH Q7, Q8 and Q9, and other applicable regulations, procedures and industry guidance.
  • Will interact with Shutdown stakeholders: Engineering, Operations, Quality, Safety, Planning, Contractors, etc.
  • Weekly/daily meeting attendance as required.
  • Participate in team led by group leaders.
  • Handle multiple projects while managing frequent interruptions.

Validation Engineer III

Job Requirements

Validation Engineer III


  • BS/BA degree in science, engineering, manufacturing technology or closely related field or combination of education and work experience.
  • Minimum of 4 years pharmaceutical validation experience recommended.
  • Experience in equipment, HVAC, utility and process qualification within a pharmaceutical industry.
  • Knowledge of ICH and other regulatory guidelines; demonstrated ability to interpret and apply these guidelines to document writing.
  • Thorough understanding of risk based validation, industry standards and best practices for validation.
  • Previous plant experience is recommended.
  • Background in aseptic processing, microbiology, environmental monitoring, chemistry, and production is recommended.
  • Requires routine sitting, standing, walking, listening and talking and moderate lifting or moving up to 25 pounds (lbs).

Validation Engineer III

Job ID: 17-01963
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