Published: June 8, 2021
- Responsible for the qualification, requalification, calibration or special tests of all plant autoclave vessels.
- Serves as a liaison between corporate laboratories for the execution of protocols, projects and validations related to new product designs, changes to product or processes that impacted the sterilization process.
- Ensures sterilization and pasteurization processes specification and procedure compliance
- Evaluates and provides disposition on autoclave aberrant cycles and qualification exceptions / OOS.
- Assure documentation is in compliance with the GDP’s and procedures requirements.
- Assure adherence to specifications and procedures.
- Responsible for quality, safety, discipline, GMP and housekeeping in the area.
- Prioritizes and schedules subordinate activities.
- Prepares, justifies and recommends department’s budget
- Interact closely with all level of the organization and external contacts
- S. in Science or Engineering, MS preferred.
- Knowledgeable of applicable CGMP’S, ISO standards, CFR, USP and EP.
- Minimum of Ten (10) years relevant experience
- Strong oral and written communications skills in Spanish & English.