Posted: 18 June
The role
Job Description
Our facility in Dunboyne joined our network in September 2020. Our Dunboyne site is our Company’s first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines. The cutting‑edge innovation and collaboration between our Company’s research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.
Our Dunboyne site now has a great opportunity for a Microbiology Technical Specialist.
What You Will Do
Operate as part of a self‑directed work team in allocating testing and assigning tasks based on priorities, including daily, weekly, monthly and quarterly tasks. Perform tasks with a high degree of precision and accuracy and ensure others do likewise.
Organise, schedule and coordinate routine day‑to‑day laboratory operations and Microbiology validation activities.
Liaise effectively with external groups such as Manufacturing, Tech Ops, CQV, Plant Engineering and QA to ensure laboratory support is available as required and testing timelines are met.
Ensure adherence to lab testing schedules, applying Lean Lab methodology.
Provide technical expertise, training and support to laboratory technicians and ensure that objectives are effectively achieved.
Ensure testing/data review are supported and that results are available within lead times to laboratory customers. Anticipated delays should be escalated, with proposed solutions for resolution.
Ensure projects are supported and completed as per project timelines. Anticipated delays should be escalated, with proposed solutions for resolution.
Author/provide leadership in the Laboratory/Contamination investigations using own initiative and with minimum supervision.
Coach and mentor the Laboratory Team.
Drive Continuous Improvement in the lab including implementation of lean projects.
Work according to Company safety policies, cGMP and cGLP.
Facilitate and drive effective communication to ensure success.
Ensure the Lab Tier/handovers are facilitated, and attendance expectations are met.
Provide support with audit/inspection requirements to ensure department compliance/readiness.
Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
Qualifications
Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
Minimum of 6‑8 years’ experience in the Microbiology Pharmaceutical industry or a similar operating environment.
Demonstrated supervisory experience.
Strong knowledge in microbiology related laboratory test methods e.g. Environmental Monitoring, Microbial Identifications, Bioburden testing, Endotoxin testing, Biological Indicator Testing, Absence of Contamination Testing (BacT), Growth Promotion/Sterility Testing.
Experience with New Product Introduction and Microbiology Method Validation experience.
Investigation experience.
Demonstrated project work/project management.
Required Skills
Analytical Method Development
Conducting Investigations
Environmental Monitoring
Microbiological Test
Microbiology Lab Techniques
Team Supervision
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
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