Supervisor, Calibration & Validation Lab

Monday-Friday 1st shift 

Position Summary 

The Supervisor, Sterilization & Microbiology will be responsible to supervise / coordinate / conduct and/or manage any micro biological, chemical and sterilization testing related to routine product development, in-process or product release quality testing, terminal sterilization, and environmental quality of products/materials impacting ICU Medical devices at the Southington, CT and Dublin, OH facilities.

Essential Duties & Responsibilities

• The position has a strong emphasis on project management to manage and coordinate activities and projects involving changes impacting ethylene oxide, radiation (Gamma and/or eBeam) sterilization cycle development, qualification, and cycle optimization with respect to parametric release, aeration, residuals, and minimization of degas times and the use of Biological Indicators (BIs).
• Coordinate proper completion of sampling and testing of products for presence of pyrogen, heparin activity testing, and bioburden levels; and, the manufacture of heparin benzalkonium complex and solution for use in catheter manufacturing
• Provide technical support to plant operations, engineering and R&D troubleshooting quality problems of a microbiological and sterilization nature, coordinating with outside services and sister facilities for problem solutions.
• Perform sterilization assessment to evaluate product changes and act as sterilization expert to support product registrations and certifications and during external regulatory audits.
• Coordinate testing of incoming components using FT-IR, melt flow, density, specific gravity, pH, and corrosion resistance
• Coordinate sampling and testing of in-house purified water, and those portions of the manufacturing process which utilize water, for presence of endotoxin and/or, microbial load, pH, TOC, and conductivity
• Coordinate all activities required to complete an appropriate sterilization of products in GAMMA irradiation and testing of biological indicators (BIs) used in the monitoring and release of ethylene oxide sterilization cycles
• Review and approve technician test results for conformance to the applicable test method; and, investigate and disposition out-of-specification test results, including the generation and participation on resolution of relevant Nonconformances and/or CAPA as required.
• Evaluate all new products, modified products, or material changes, to assess sterilization and biocompatibility impact per the requirements of ISO 10993.  Coordinate micro-challenge and biocompatibility testing when necessary
• Fulfill administrative responsibilities of budgeting, staffing, performance review for the Biological Quality Laboratories at  Southington, CT. and Dublin, Oh.
• Ensure all processes described are completed in compliance with applicable industry regulations/standards and ICU Medical procedures and update applicable procedures as needed to ensure compliance to new or revised microbiology, clean room and sterilization industry standards.
• Act as Subject Matter Expert for qualification and audits of sterilization suppliers.
• Performs other functions as necessary or as assigned

 

Knowledge, Skills & Qualifications

• Familiarity with cGMP, cGLP, FDA, and compendial guidelines governing the manufacture and release of sterile, single-use medical devices
• Good organizational and communication skills required
• Knowledge of Microsoft Word, Excel, and Outlook

 

Education and Experience 

• BS degree or equivalent experience in biological or chemical science required
• Min 5 years’ experience in a related field
• Ability to supervise and manage projects and subordinates to accomplish departmental goals in a timely manner

 

Travel Requirements 

• This position will be located at the Southington, Ct facility with some travel to the Dublin, Oh facility. Typically requires travel 10% of the time.

 

Physical Requirements and Work Environment 

• Work is performed in an office environment
• May perform job functions within the laboratory
• While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
• Must be able to occasionally move and lift objects of up to 25 lbs

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. 

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.

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