You will support the Sterilization organization to facilitate efficient operations, to optimize existing processes, and to ensure that production, quality and regulatory compliance goals are met.
This is a permanent job and you will work cross-functionally to understand process impact on products, evaluate process development and validation, and ensures efficient and effective transfer of product into production.
Your Responsibilities Will Include:
- Initiates and completes technical activities leading to new or improved sterilization processes to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.
- Understands engineering principles theories, concepts, practices and techniques. Develops knowledge in a field to become a recognized leader or authority in sterilization and applies this knowledge in leadership roles in the company.
- Applies technical knowledge to innovate, design, and develop processes and procedures.
- Assesses sterilization process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
- Executes and supports the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Supports technical reviews.
- Ensures proper documentation is completed to meet quality systems requirements. (e.g., Technical Reports, FMEA’s, etc.)
- Writes and reviews experimentation and validation protocols and reports applicable to products and sterilization processes.
- May serve as a core team member or extended team member on new product projects or process improvement initiatives related to sterilization.
- Provides assistance and support to the sterilization operations, regulatory, and quality groups as required.
- Min 3 years of experience in roles related to Sterilization or Microbiology with BS degree, or MS degree in Microbiology, Biochemistry, or related discipline.
- Strong troubleshooting and problem solving skills
- Experience with IQ, OQ and PQ processes
- Experience with multiple industrial sterilization processes and modalities
- Strong technical knowledge of Ethylene Oxide Sterilization processes and equipment preferred.
- Demonstrated understanding of medical device regulatory requirements and quality system an asset.
- Pro-active, energetic, self-assured professional with high personal integrity and ability to collaborate, influence and develop positive interpersonal relationships.
For more information, please contact Emma on 091 455 307.
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