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Cleaning Validation Engineer

Location: Raleigh, NC

Job Description

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.
  • Also to lead the cleaning validation program and activities.
  • 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” 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.

About Azzur
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. 

Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun! 


Apply Now
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