Microbiology Subject Matter Expert

at  Alcon

Microbiology Subject Matter Expert
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

As an Microbiology Subject Matter Expert you are tasked to Site Subject Matter Expert (SME) in microbiological and sterility assurance, environmental monitoring program and cleanliness control strategies. Manage and lead a team of Micro QC Lab associates to perform inspection and testing of products to meet quality standard according to established Standard Operating Practices (SOP), as well as any applicable federal regulations or industry standards at Tuas. In this role, a typical day will include:

• A Subject Matter Expect (SME) of Microbiological and Sterility Assurance test who will need to actively network with the internal and external scientific, technical and establish regulatory community to maintain state of the art knowledge.
• Establish company policy and developing company strategies with respect to cleanliness, sterilization, clean rooms, pure water systems and related areas.
• Provide micro-SME support to the site and assist in new product development and provide input in the design of manufacturing processes, water systems, controlled environments, and packaging from a microbiological standpoint.
• Have responsibility for the site environmental monitoring program and cleanliness control strategies.
• Work with cross-functional team to establish, validate and maintain clean manufacturing environments, processes, and utilities.
• Issue, conduct NCR and OOS investigation as a certified investigator, identify root cause and determine appropriate CAPA. Ensure all TW records are closed timely.
• Responsible for compliance to applicable Quality Regulations, ISO, and AAMI standards, and other regional and safety standards
• Lead a team of Microbiology associates and ensure microbiology inspection and testing activities are executed in compliant to local SOP, Alcon corporate standards, and regulatory requirements. Provide direction and supervision to direct reports. Conduct career dialogue and follow up on individual development plan. Ensure backup for all roles and responsibilities.
• Lead and execute continuous improvement initiatives to improve productivity, efficiency, and cost optimization.
• Support internal and external audits and is responsible for audit finding closure, as required.
• Ensure zero HSE incidents

What You’ll Bring to Alcon

• Preferably Bachelor’s degree in Microbiology, Biological Science, Life sciences or equivalent discipline
• 7 to 10 years relevant working experience in medical device or pharmaceutical industry with a good understanding of the following cGMP and ISO requirements

Why Join Us:

• Opportunity to work with a leading global medical device company.
• Collaborate with a diverse and talented team in a supportive work environment.
• Competitive compensation package and comprehensive benefits.
• Continuous learning and development opportunities.

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• A Subject Matter Expect (SME) of Microbiological and Sterility Assurance test who will need to actively network with the internal and external scientific, technical and establish regulatory community to maintain state of the art knowledge.
• Establish company policy and developing company strategies with respect to cleanliness, sterilization, clean rooms, pure water systems and related areas.
• Provide micro-SME support to the site and assist in new product development and provide input in the design of manufacturing processes, water systems, controlled environments, and packaging from a microbiological standpoint.
• Have responsibility for the site environmental monitoring program and cleanliness control strategies.
• Work with cross-functional team to establish, validate and maintain clean manufacturing environments, processes, and utilities.
• Issue, conduct NCR and OOS investigation as a certified investigator, identify root cause and determine appropriate CAPA. Ensure all TW records are closed timely.
• Responsible for compliance to applicable Quality Regulations, ISO, and AAMI standards, and other regional and safety standards
• Lead a team of Microbiology associates and ensure microbiology inspection and testing activities are executed in compliant to local SOP, Alcon corporate standards, and regulatory requirements. Provide direction and supervision to direct reports. Conduct career dialogue and follow up on individual development plan. Ensure backup for all roles and responsibilities.
• Lead and execute continuous improvement initiatives to improve productivity, efficiency, and cost optimization.
• Support internal and external audits and is responsible for audit finding closure, as required.
• Ensure zero HSE incident