Jr. Validation Specialist - Autoclave
Is responsible for operating, monitoring, and documenting sterilization processes in a GMP-regulated environment. This role supports manufacturing operations by ensuring product sterilization in accordance with established procedures, quality standards, and regulatory requirements. The ideal candidate has a 1–2 years of relevant experience, and the ability to work on-site during administrative business hours.
Responsibilities
- Operate autoclave equipment following approved Standard Operating Procedures (SOPs), cGMPs, and safety requirements.
- Prepare, load, unload, and monitor sterilization cycles of manufacturing process.
- Verify and document critical process parameters, including temperature, pressure, and cycle duration.
- Maintain accurate records, logs, and documentation in compliance with Good Documentation Practices (GDP).
- Perform routine cleaning, inspection, and basic maintenance of autoclave equipment.
- Ensure timely handling and processing of sterilized materials to support production activities.
- Report equipment malfunctions, deviations, and non-conformances to management.
- Support investigations, corrective actions, audits, and regulatory inspections.
- Adhere to all company policies, safety procedures, and quality standards.
- Collaborate effectively with Quality Assurance, Manufacturing, and Facilities teams.
Requirements
- Associate’s or Bachelor’s degree in Engineering, Microbiology, Biotechnology, Chemical, or a related scientific field.
- 1–2 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or laboratory environment.
- Previous experience operating autoclaves or other sterilization equipment preferred.
- Understanding of sterilization processes, aseptic techniques, and microbiological principles.
Available
- Availability to work on-site in an administrative schedule (Monday–Friday).
- Available to work om-site
Work Location: In person
