Microbiology Technical Specialist

Our facility in Dunboyne joined our network in September 2020. It is the 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 research and manufacturing teams accelerates the time to bring a medicine to market for the benefit of patients worldwide.

What you will do:

• Operate as part of a self directed work team allocating testing and assigning tasks based on daily, weekly, monthly and quarterly priorities.
• Perform tasks with a high degree of precision and accuracy, ensuring 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 objectives are effectively achieved.
• Ensure testing/data review are supported and results are available within lead times to laboratory customers; anticipate delays and propose solutions for resolution.
• Ensure projects are supported and completed according to project timelines, escalating anticipated delays with proposed solutions.
• Author and provide leadership in laboratory contamination investigations with minimal 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 laboratory 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, acting as auditee for assigned areas.

In order to excel in this role, you will more than likely have:

• Bachelor's degree or higher, preferably in microbiology or a closely related discipline.
• Minimum 6-8 years' experience in the microbiology pharmaceutical industry or a similar operating environment.
• Demonstrated supervisory experience.
• Strong knowledge of microbiology laboratory test methods such as environmental monitoring, microbial identification, 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.
• Investigation experience.
• Demonstrated project work and project management experience.

Required Skills:

• Analytical method development
• Conducting investigations
• Environmental monitoring
• Microbiological testing
• 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.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office based colleagues around the world.