Senior Microbiologist / SterilISAtion Sc

ICDS Recruitment

Galway

Senior Microbiologist / Sterilisation Scientist Galway Job Responsibilities: Act as project lead for sterilization validations/annual revalidations, test protocols/reports for external sterilization and laboratory providers. Act as a sterilization and microbiology subject matter expert on projects that have global impact and influence across multiple regions and business units. Provide technical expertise to address issues arising from sterilization non-conformances and recommend long-term solutions for prevention, when possible. Analyze the impact/efficacy of existing sterilization methods on new products or new product designs. Act as sterilization expert for teams bringing new products to market completing the sterilization strategies for those products. Evaluate the impact of new or modified manufacturing related changes on existing sterilization methods. Recommend and/or evaluate alternative sterilization methods, facilities, and processes as needed to support manufacturing objectives. Maintain and assist in managing the sterilization program/policy to ensure all products and processes comply with global regulatory standards. Create, charter, and implement strategies to assure compliance to regulatory standards regarding sterilization for products. Act as sterilization subject matter expert during audits of internal and external sterilization suppliers according to a documented audit plan. Act as sterilization subject matter expert during regulatory audits & inspections. Provide oversight and ensure company-wide, consistent and compliant methods for the following: EO Residuals, bioburden monitoring, environmental monitoring, cleanroom practices, water systems and bacterial endotoxin testing. Mentor and train appropriate company personnel on sterilization and microbiological methods and processes as needed. Ensure company documentation related to sterilization and microbiological controls are maintained and updated with most current regulations, standards, and industry practices. Key Requirements: B.S. Degree in Biology, Biochemistry or Microbiology is preferred with a minimum of 7 years of experience in industry. Excellent communication skills (written and verbal. Regulatory, cGMP, QSR knowledge base. Statistical knowledge (DOE, SPC, Sample comparison, etc.) Proficient in Microsoft Office Suite and MiniTab. Negotiation and strong problem solving skills. Ability to lead teams efficiently and effectively. Ability to communicate and operate effectively with multiple teams. Ability to manage multiple tasks in order to meet/exceed deadlines. Expertise and extensive knowledge in EO and gamma radiation sterilization. Capability to adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts, reasoning ability. SPECIALIZED SKILLS & OTHER REQUIREMENTS: Supplier audit certification required/highly recommended. 7 or more years of experience in EO sterilization. Experience dealing with bioburden out of limit investigations. Experience with bacterial endotoxin (LAL) testing. Experience as an SME with Notified Body Audits to EN ISO 11135-1. TRAVEL REQUIRED: 10-25 % This job originally appeared on RecruitIreland.com.

2489 days ago