At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. **We are seeking a Cleaning Validation Specialist for an opportunity in Raleigh-Durham, NC.**

**Objectives of this Role:** * 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 existing manufacturing rooms and sampling suites areas.

* Design and support the implementation of cleaning strategies for product transfer projects and product development projects.

* Investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results for non-validated or under development cleaning procedures.

* Lead the enhancement of cleaning practices, clean in place equipment and introduction.

* Review and approve Manufacturing Cleaning Working Instructions and Forms.

* Support the periodic review of cleaning validation studies.

* Perform successful and on time resolution of incidents and deviations related to cleaning validation exercises.

* Issue Change Controls required for the implementation of cleaning procedure changes, as needed.

* Train manufacturing and QC/QA personnel on cleaning validation documentation.

* Bachelor's or masters degree in Science, Pharmacy or Engineering.

* Minimum of 3 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.

* Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.

* Proficient time management skills, planning and organization capabilities.

* Proven team player, self-starter, results oriented and able to build 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.

* Proficient in cGMP's and FDA Regulations as it applies to pharmaceutical industry.