Cleaning Validation Specialist

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 and handling of oral solids drug (OSD) products.
• 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  Engineering.
• Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries (Oral Solid).
• 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/Spanish) 
• Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.

Additional Information

Positions available for Puerto Rico.

Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.