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Cleaning Validation Expert
2 months ago
PSC Biotech, a leading Biotech Consultancy firm, is seeking a Cleaning Validation Subject Matter Expert 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:- Monitor cleaning validation, develop cleaning cycles, and validate cleaning in a cGMP facility.
- Analyze data, determine results, and present conclusions and recommendations to ensure projects are implemented in accordance with the agreed scope, timelines, policies, and procedures.
- Generate and resolve protocol discrepancies or deviations, review GxP deliverables, and train operations staff on protocols, procedures, and technical details related to systems or processes.
- Develop cleaning procedures that minimize cycle time, water, chemicals, and unnecessary motion, and generate reference documents and cleaning SOPs based on cleaning cycles.
- Write technical cleaning evaluations, including calculations such as maximum allowable residue carryover from product to product, and deviations with root cause and impact assessment.
- A minimum of a Bachelor's degree from an accredited university.
- 4+ years of experience in cleaning validation in the Pharmaceutical or Biotech industry.
- Ability to work independently with minimum supervision and excellent oral and written communication skills.
- Problem-solving skills, attention to detail, and ability to handle multiple responsibilities and projects.
