Sterilization Assurance Specialist

hace 4 semanas


Paraíso, Paraíso, Costa Rica Nextern A tiempo completo

This position plays a pivotal role in ensuring the successful management of sterilization requirements at Nextern, fostering seamless collaboration between key stakeholders.

The Sterilization Assurance Specialist will be instrumental in guaranteeing that customer and regulatory expectations are met before and after the sterilization process. This involves maintaining and implementing process improvements in products and development programs to ensure they are carried out in an appropriate and timely manner, adhering to Nextern business procedures and requirements.

Key responsibilities include determining if bioburden testing is required per the working instruction, preparing samples from batch, and completing Test Requests Forms. Additionally, the specialist will be responsible for reviewing cycle run data, bioburden and endotoxin trending, sterile release traveler preparation, and prepping samples/pallets for Biennial MPQ/PPQ Runs.

The role also involves Routine Sterilization Monitoring Plans, Sterile Prep Work Instructions, and working with Quality on creating a sterile release traveler. Annual reviews and support for Micro ISO Audits are further aspects of this challenging yet rewarding position.

To excel in this role, candidates should possess a University degree in Life Sciences, Engineering, or Microbiology and have at least two years of experience in Sterilization activities in regulated industries like Medical Devices or Pharmaceuticals. An advanced level of English (B1+, C1 Belt) is also essential.

A competitive compensation package and an exceptional working environment make this a truly attractive opportunity.



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