We have a current opportunity for a Senior Sterilization Engineer on a permanent basis.
This position will oversee the moist heat sterilization of medical devices for the Kidney Care division in Minnesota. Responsibilities include collaboration with contract manufacturing plants and sterilization vendors to qualify medical devices and provide expertise to sustain existing products. The role also involves developing and qualifying sterilization processes for pharmaceutical and medical device products, providing sterility assurance recommendations, and ensuring compliance with Quality system and cGDP/cGMP practices.
Key Responsibilities:
- Sterilization Process Development and Qualification:
- Lead technical support groups in planning and executing sterilization process qualifications.
- Interpret and apply sterilization standards to support product sterility assurance.
- Develop and drive qualification plans, documenting results and conclusions.
- Sterility Assurance:
- Provide recommendations on sterility assurance and microbial control for new product development and sustaining existing products.
- Evaluate all aspects of sterility assurance, ensuring alignment with Quality system and cGDP/cGMP practices.
- Collaboration and Communication:
- Work with product development teams, design owners, laboratory, and manufacturing personnel.
- Regularly update Sterility Assurance management on project progress and outcomes.
- Innovation and Problem-Solving:
- Devise innovative approaches to complex problems through adaptations and modifications of standard technical principles.
Required Qualifications:
- Education:
- Degree in Chemical Engineering, Mechanical Engineering, or a related field.
- B.S. with over 4 years of related experience or M.S. with over 2 years of related experience.
- Experience:
- Strong engineering background with experience in moist heat/steam sterilization.
- Demonstrated ability to manage multiple simultaneous work activities.
- Knowledge of medical device and/or pharmaceutical sterilization.
- Experience in GDP/GMP/GLP practices.
- Skills:
- Strong statistical background with the ability to apply statistical analysis to data sets.
- Ability to convince management on courses of action using both written and verbal communication.
- Effective operation in cross-functional teams with limited guidance.
Desirable Skills:
- Experience in pharmaceutical or medical device manufacturing.
- Knowledge of other sterilization modalities such as radiation.
- Proficiency in Minitab.
- Experience working in a manufacturing environment.
Working Conditions:
- This role may require occasional travel to contract manufacturing plants and sterilization vendors.
- Must be able to work effectively in a fast-paced, collaborative environment.
Application Process:
Interested candidates should submit a resume and cover letter detailing their qualifications and experience related to the responsibilities and requirements of the position.
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