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Validation Specialist
QRC Group, IncHumacao, Humacao, Puerto RicoHace 3 días
Descripción del trabajoExperience with cleanroom environments and aseptic processing. Familiarity with risk-based validation approaches and root cause analysis . Ability to work independently and manage multiple projects simultaneously. Bachelor’s degree in Engineering, Life Sciences, or a related field. 2–5 years of experience in validation, with a focus on steam sterilization systems. Excellent technical writing and documentation skills. Bilingual (Spanish / English)
Job Description
Validation Specialist with hands-on experience in small steam sterilization systems (e.g., autoclaves, SIP systems). This role is responsible for ensuring that equipment, utilities, and processes meet regulatory and operational standards through the execution of validation protocols and documentation.
Key Responsibilities :
- Develop and execute IQ / OQ / PQ protocols for small steam systems, including autoclaves and SIP (Steam-in-Place) equipment.
- Perform thermal mapping , biological indicator testing , and cycle development for steam sterilization processes.
- Analyze validation data and prepare comprehensive reports in compliance with GMP , FDA , and ISO standards.
- Collaborate with cross-functional teams (QA, Engineering, Manufacturing) to support validation activities and resolve discrepancies.
- Participate in deviation investigations , CAPAs , and change control assessments related to validated systems.
- Support audits and inspections by providing validation documentation and technical expertise.
Preferred Skills :
Qualifications
Additional Information
All your information will be kept confidential according to EEO guidelines.