Cleaning Validation Specialist

Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services. 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.   - 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.    Positions available for Puerto Rico. Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.