Senior Validation Engineer with Pharmaceutical and cleaning validation expertise in Mount Prospect, IL on W2 basis

Overview

On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)

Skills

cleaning validation
Pharmacy or Engineering
Risk Assessment/

Job Details

Senior Validation Engineer: Pharmaceutical experience, ideally with cleaning validation expertise.

From the manager .

For the validation role, I would love to get someone with cleaning validation experience to help me change the way we do cleaning. Currently, we do a quick validation on every solution and piece of equipment. I would like to move to a risk-based approach where we evaluate new products and equipment against the current worst-case to determine what needs to be done. It s a big change. I m not an expert on it, so having someone to help would be awesome.

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.
  • Experience mixing solutions (formulations)
  • 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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