Sterilization Process Manager
hace 3 semanas
This position is responsible for ensuring that sterilization and product final release meet customer and regulatory expectations. The Sterilization Assurance Specialist will manage sterilization requirements between Nextern, Sterilization Supplier, and key clients. They will ensure that all sterilization processes are carried out in an appropriate and timely manner, according to Nextern business procedures and requirements.
The role involves maintaining and implementing process improvements in products and development programs. This includes actively interacting with project managers, production, quality assurance, and supply chain personnel, as well as process development engineers and other supporting roles at Nextern sites.
Main Responsibilities:
- Determining if bioburden testing is required per the WI and preparing samples from batch.
- Determining quantity of endotoxin samples (if required per WI) and preparing samples from batch.
- Completing Test Requests Forms per WI: sterility TRF, endotoxin TRF, bioburden TRF, and microbiological services TRF.
- Reviewing cycle run data.
- Bioburden and endotoxin trending.
- Preparing sterile release traveler.
- Preparing samples/pallets for Biennial MPQ/PPQ Runs.
- Routine Sterilization Monitoring Plans.
- Sterile Prep Work Instructions.
- Working with Quality on creating a sterile release traveler.
- Annual reviews.
- Biennial MPQ/PPQ Runs.
- Sterility impact for design change plans.
- Supporting Micro ISO Audits.
Requirements:
- University degree in Life Sciences, Engineering, or Microbiology.
- Two or more years of experience in Sterilization activities in regulated industries like Medical Devices, Pharmaceutical.
- Advanced level of English B1+, C1 Belt.
- Demonstrated high level competencies in accountability, teamwork, communicating effectively, and advanced planning and organizing skills.
Benefits:
Competitive compensation package and an exceptional working environment.
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