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.
- 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.
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.
