*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:*
* Experience 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.
Requirements
* 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 Types: Full-time, Contract
Schedule:
* Monday to Friday
Work Location: In person
