Company Microbiologist - South Dublin

Company Microbiologist - South Dublin.

In this role you will be accountable for ensuring that all products produced at the site adhere to the specified microbiological and sterilization standards.

Responsibilities:

• Responsible for maintaining up-to-date knowledge of all current relevant worldwide regulatory requirements that relate to products manufactured at this location

• Manage daily operations of the in-house microbiology laboratory, ensuring timely and accurate testing and equipment maintenance

• Setting of appropriate microbiological quality standards for all products, and implementation across the site in compliance with all sterilisation and environmental monitoring requirements

• Work with cross-functional teams to support the radiation sterilization validation and routine monitoring for all products.

• Responsible for overseeing, approving and maintaining the Dose establishment, Bioburden testing, sterility testing, endotoxin testing and environmental monitoring programs for the site.

• Responsible for Risk assessments to support the sterility assurance activities on site.

• Responsible for determination of sterility assurance requirements for the site change control program.

• Responsible for all Sterility assurance and microbiology related out of specification investigations, non-conformances and CAPA.

• Responsible for the sterilization product release program for all products from the site.

• Act as Microbiology and Sterilization Technical Specialist and SME for the site, and participate in audits to represent the sterility assurance function.

• Act as an internal auditor supporting the site internal audit program.

• Integrate and collaborate with appropriate technical specialist groups.

• Responsible for the validation and maintenance of environmental monitoring programs, and environmentally controlled manufacturing areas for the site.

Interested applicants should have:

• Degree in Science or a related Quality discipline specialising in Microbiology

• At least 8 years' experience in a similar role, preferably in a medical devices, pharmaceutical or biologics manufacturing environment, experience supervising personnel and managing projects.

• Radiation and terminal sterilization experience would be advantageous

• Excellent interpersonal, communication and team building skills

• Must be computer literate

• Experience in process validation, sterilization and working in a cleanroom environment would be advantageous.