Experience Requirements
The primary areas of responsibility for this position are project management and development of systems for global Sterility Assurance, biocompatibility, environmental monitoring, coordination of routine contract sterilization and laboratory services, and microbiology.
Qualification Requirements
Regulatory: ISO (sterilization, cleanroom, and biocompatibility) and cGMP knowledge base. Project management skills. Computer literate (Microsoft Word and Excel, QAD, OnQue, Pilgrim Q&MIS). Negotiation and problem solving skills. Ability to organize and implement multiple projects at a time. Ability to adapt to many different job responsibilities. Ability to operate and communicate effectively departmentally and interdepartmentally. Ability to operate and communicate effectively with outside suppliers. Laboratory bench skills. Reasoning ability, support and prioritize projects, adapt to shifting priorities, work with minimal supervision, able to resolve problems / conflicts.
Preferred Qualifications
B.S. degree or equivalent in Biology, Microbiology, or a similar scientific discipline plus 8+ years related experience in specific areas of, industrial sterilization biocompatibility, and environmental monitoring. Must have a minimum of 8 years of experience.
Responsibilities
Oversee, develop, and manage all microbiology aspects of global product transitions including sterilization validations, biocompatibility review and testing, reusable cleaning and sterilization studies, and accelerated or real-time aging studies. Oversee and develop systems for all areas of global sterility assurance including terminally-sterilized product sterilization validations (i.e. EtO, gamma), reusable cleaning and sterilization studies, routine contract sterilization and applicable laboratory services. Oversee and develop global systems for the review and testing of the biocompatibility of materials per ISO and FDA standards. Oversee microbiological aspects of new product development with respect to sterilization processes/validations, biocompatibility requirements, accelerated and real-time aging, and microbiology. Supervise a microbiologist and product release coordinator at RTP.
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