A Validation Engineer with Autoclave and Fieldwork responsibilities is responsible for ensuring that the sterilization process of equipment and devices used in the pharmaceutical, medical device, and biotech industries meet regulatory standards. The engineer will be responsible for testing, validating, and maintaining the autoclaves, and also ensuring that the fieldwork activities associated with the sterilization process are performed in compliance with relevant regulations and standards. The job description for this role may include the following:
Responsibilities:
- Conduct validation tests for the autoclaves used in the sterilization process, including temperature mapping, biological indicator testing, and validation protocol execution.
- Create, review and approve validation documentation including protocols, reports, and standard operating procedures (SOPs).
- Maintain accurate records of autoclave performance, including calibration, preventive maintenance, and repair activities.
- Conduct fieldwork activities related to the sterilization process, including equipment inspection, cleaning, and validation.
- Coordinate with production and quality control departments to ensure that sterilization processes are in compliance with regulatory standards.
- Perform risk assessments and identify process improvements to optimize the sterilization process.
- Provide training to personnel involved in the sterilization process, including production operators and quality control personnel.
- Participate in audits and inspections to ensure that the sterilization process is in compliance with regulatory requirements.
Requirements:
- Bachelor’s degree in engineering, biology, or a related field.
- At least 2-5 years of experience in a validation engineering role with autoclave and fieldwork responsibilities.
- Strong knowledge of regulatory requirements and industry standards related to sterilization processes.
- Familiarity with validation protocols and documentation, including IQ/OQ/PQ, process validation, and equipment qualification.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
- Ability to work independently and manage multiple projects simultaneously.
- Willingness to travel for fieldwork activities.
- Knowledge of statistical process control and data analysis tools is a plus.