Provide overall facility guidance on developments, trends and observed issues related to Microbiology Analysis. Support the Lab Manager in projects and day to day micro Lab management. Develop the Microbiological direction for the facility and implement current Microbiology Lab test methodologies and practices to support product, environment and utility testing, in order to ensure products are tested in accordance with established methods and in compliance with applicable regulatory and Alcon corporate requirements.
1.Site responsible to manage environmental controls. 2. Assist Laboratory Manager: a) in projects and day to day micro Lab management; b) supporting audit readiness activities and interact directly with internal and external auditors as SME; c) supporting and managing projects to be on time, within budget and to meet business requirements; d) introducing new systems, processes and products, compliant with applicable requirements. 3. Develop and implement best practice Micro test methodologies for the facility to support product, environment and utility testing. Design and manage laboratory process improvement projects and validations. Up to date on current and future microbiology technical and regulatory trends and developments and ensure Lab operations are updated to reflect same and maintained in validated state. 4. A key contributor and driver for executing investigations relating to environmental and product microbiological out of specification results and driving the identification of root cause and implementation of agreed CAPAs. 5. Strong trouble-shooting skills and ability to work in dynamic cross-functional teams. 6. Assure that all microbiology testing and operational procedures and practices comply with current regulatory industry best practices requirements and corporate standards. Interpret microbiology results and resolve technical and/or operational problems; and provide technical advice and support to other departments within the facility. Engage in the training and mentoring of laboratory associates to develop and increase the level of expertise within the laboratory. Demonstrate a proactive approach towards identifying issues which may impact the quality of product through tracking & trending of data, considering all appropriate sources of quality data. 7. Provides work direction / supervision for direct reports (if any): participates in hiring process, produces performance evaluations, and supports career and professional development of Microbiology team.
Key Performance Indicators:
Complete understanding and wide application of technical principle, theories, and concepts in the field. General knowledge of other related disciplines.
Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organizational objectives. Works under only general direction.
Bachelor's degree from an accredited institution in a Microbiology or related technical discipline. Preferred: Masters in Microbiology.
Excellent verbal and written English.
Minimum 2 years of related work experience. Preferred: 5 years of related experience in a sterile Medical Device.
Manufacturing /Pharma environment. People management / leadership experience.