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Validation Engineer

Job in Mount Prospect, Cook County, Illinois, 60056, USA
Listing for: 3B Staffing
Full Time position
Listed on 2026-06-02
Job specializations:
  • Engineering
    Quality Engineering, Validation Engineer, Pharma Engineer
Job Description & How to Apply Below
Validation Engineer

Coordinate cleaning validation activities. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies. Oversees and reviews validation area processes.
  • Design and develop cleaning procedures for new products and manufacturing equipment.
  • Provide technical support to cleaning activities associated with the manufacturing process.
  • Use of cleaning agents and the establishment of sound cleaning practices within new or refurbished manufacturing rooms and sampling suites areas.
  • Designs and supports the implementation, i.e. provides training, of cleaning strategies for product transfer projects and product development projects.
  • Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non validated or under development cleaning procedures.
  • Leads the enhancement of cleaning practices, "clean in place" (CIP) equipment and introduction.
    Reviews and approves Manufacturing Cleaning Working Instructions and Forms.
  • Supports the periodic review of cleaning validation studies.
  • Performs successful and on time resolution of incidents and deviations related to cleaning validation exercises.
  • Issues Change Controls required for the implementation of cleaning procedure changes, as needed.
  • Trains manufacturing and QC/QA personnel on cleaning validation documentation.
Qualifications
  • Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
  • Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
  • Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
  • Strong project management skills.
  • Proficient time management skills, planning and organization capabilities.
  • Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
  • Proficient in Risk Assessment/Management
  • Proven assessment, analytical and problem-solving skills.
  • Proficient presentation skills and Technical Writing/Oral communication skills (English)
Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry
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