Process Validation Specialist (ETO) at QRC Group, Inc

Caguas, , -

Full Time

Start Date

Immediate

Expiry Date

22 May, 26

Salary

0.0

Posted On

21 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Ethylene Oxide Sterilization, IQ/OQ/PQ, Load Configuration Studies, Gas Penetration Tests, Thermal Distribution Assessments, Residuals Evaluations, Microbiological Analysis, Physicochemical Analysis, ISO 11135, ISO 10993-7, ISO 13485, FDA Regulations, EMA Regulations, Statistical Analysis, SOP Maintenance

Industry

Staffing and Recruiting

Description

Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description Process Validation Specialist with experience in ethylene oxide (ETO) sterilization processes comply with applicable regulatory, quality, and industry standards, guaranteeing process effectiveness, reproducibility, and safety for medical or industrial products. Responsibilities: Develop, execute, and document IQ/OQ/PQ validation protocols for EtO sterilization processes. Conduct load configuration studies, gas penetration tests, thermal distribution assessments, and residuals evaluations. Analyze microbiological, physicochemical, and process performance data. Ensure compliance with applicable standards such as ISO 11135, ISO 10993-7, ISO 13485, and FDA/EMA regulations. Manage process changes through impact assessments and revalidations. Prepare technical reports, scientific justifications, and supporting documentation for internal and external audits. Collaborate with Quality, Engineering, Manufacturing, and Supplier teams to resolve deviations or nonconformities. Participate in continuous improvement initiatives, process optimization, and reduction of EtO residuals. Maintain and update standard operating procedures (SOPs) related to sterilization. Qualifications Bachelor Degree Engineering (Industrial, Chemical, Biomedical), Microbiology, Sciences, or related fields) 4 years of experience in process validation (ETO) Strong understanding of EtO sterilization processes and critical parameters (humidity, temperature, concentration, exposure time). Solid knowledge of microbiology applied to sterilization. Proficiency with statistical analysis tools (Minitab, JMP, etc.). Experience in process validation within regulated environments. Familiarity with quality management systems (QMS). Ability to interpret international standards and regulatory requirements. Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The specialist will be responsible for developing, executing, and documenting IQ/OQ/PQ validation protocols for EtO sterilization processes, including conducting various related studies like load configuration and gas penetration tests. They must also analyze microbiological and physicochemical data, ensure compliance with standards like ISO 11135, and manage process changes through impact assessments and revalidations.