Cleanstep Pharma & Engineering Solutions (Validation/Consulting)
Website:
cleanstep.in
Job details:
Company Description
Cleanstep Pharma & Engineering Solutions specializes in comprehensive pharmaceutical validation and consulting services. With expertise across critical areas such as Airflow Visualization Studies, Computer System Validation (CSV), and Thermal Validation, the company ensures compliance and quality within the pharmaceutical and engineering sectors. Their services extend to LIMS Master Data Management, Sterilizers Validation, HVAC systems, and testing of Pure Steam Quality, Compressed Air, and Gases. Additionally, Cleanstep provides Third-Party Auditing services, delivering tailored solutions to meet industry standards.
Role Description
This is a full-time on-site role for a Subject Matter Expert, located in Hyderabad. The Subject Matter Expert will oversee and execute a variety of validation and consulting tasks, including airflow visualization studies, thermal validation, sterilisers validation, and computer system validation (CSV). Responsibilities also include managing and creating LIMS Master Data, thermal mapping, and conducting quality tests for HVAC, compressed air, gases, and pure steam. The role involves ensuring strict compliance with industry standards and participating in third-party audits as required.
Qualifications
- Proficiency in Airflow Visualization Studies, Thermal Validation, and Validation of Sterilizers
- Experience with Computer System Validation (CSV), LIMS Master Data Creation, and Management
- Demonstrated skills in HVAC, Pure Steam Quality Testing, Compressed Air Testing, and Gases Testing
- Ability to assist with and conduct Third-Party Auditing and ensure compliance with relevant protocols and standards
- Strong problem-solving, documentation, and reporting skills
- Knowledge of current pharmaceutical regulatory requirements and best practices
- Bachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, or a related technical field
- Excellent analytical skills with the ability to work in on-site team environments
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