Supervisor, Calibration & Validation Lab

ICU Medical•Southington, CT

40d•Onsite

About The Position

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

Requirements

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
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

Responsibilities

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.
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