Cleaning Validation Subject Matter Expert

3 weeks ago

Lewisville, United States CareerBuilder Full time

PSC Biotech | Consultant
**Cleaning Validation Subject Matter Expert**
Lewisville , United States | Posted on 08/12/2021
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Work Experience

4-5 years

**Job Description**
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our clients success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customers expectations.
We are looking for a Cleaning Validation SME to support one of our clients in Lewisville, TX. The ideal candidate will have the ability to execute cleaning and sanitation development and validation protocols independently following cGxP and communicate as part of a team in a cGMP Facility.

**Responsibilities:**
* The position involves cleaning validation monitoring, cleaning cycle development and cleaning validation in a cGMP facility.
* Must be able to analyze data, determine results and present conclusions and recommendations ensuring that projects are implemented in accordance with the agreed scope timelines, policies and procedures, generate and resolve protocol discrepancies or deviations, review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation and train operations staff on protocols, procedures and technical details related to systems or processes.
* Generate and resolve protocol discrepancies or deviations.
* Review GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation and train operations staff on protocols, procedures and technical details related to systems or processes.
* Generate reference documents and cleaning SOPs based on the cleaning cycles. Develop cleaning procedures that minimize cycle time, water, chemicals, and unnecessary motion.
* Write technical cleaning evaluations as requested, including calculations such as maximum allowable residue carryover from product to product, and deviations with root cause and impact assessment.
* May perform other cleaning and sanitation validation related duties as assigned.
**Requirements**
* A minimum of a Bachelors degree from an accredited university
* 4+ years of experience in cleaning validation in the Pharmaceutical or Biotech industry.
* Ideal candidate must be able to work independently with minimum supervision and have excellent oral and written communication skills.
* Ideal candidate must be a problem solver; detail oriented, and must be able to handle multiple responsibilities and projects.
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