Company Microbiologist

Sigmar Recruitment; South Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

A prestigious recruitment agency is seeking a Company Microbiologist to ensure compliance with microbiological and sterilization standards at their Dun Laoghaire location. The ideal candidate will have over 8 years of experience in a similar role within medical devices or pharmaceuticals, strong interpersonal skills, and a relevant degree in Science. Responsibilities include managing laboratory operations, setting quality standards, and supporting sterilization validation. This role offers an opportunity to work in a dynamic environment with a focus on quality assurance.

Qualifications

• 8+ years experience in a similar role, preferably in medical device, pharmaceutical, or biologics environment.
• Experience supervising personnel and managing projects.
• Radiation and terminal sterilization experience would be advantageous.

Responsibilities

• Ensure products meet microbiological and sterilization standards.
• Manage daily operations of in-house microbiology laboratory.
• Set microbiological quality standards and implement across the site.
• Support radiation sterilization validation and routine monitoring.

Skills

Excellent interpersonal skills

Communication skills

Team building skills

Computer literacy

Education

Degree in Science or related Quality discipline

Tools

Microsoft Office software

Job description

Overview

The Company Microbiologist is accountable for ensuring that all products produced at the Dun Laoghaire 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 the Dun Laoghaire 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 Dun Laoghaire site
• Act as microbiology and sterilization technical specialist and SME for the Dun Laoghaire 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 embecta technical specialist groups
• Responsible for the validation and maintenance of environmental monitoring programs, and environmentally controlled manufacturing areas for the site
• Any other reasonable duties which may be required by management from time to time

Educational Requirements and Relevant Experience

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

Knowledge, Skills and Abilities

• Excellent interpersonal, communication and team building skills
• Must be computer literate with knowledge of Microsoft Office software an advantage
• Experience in process validation, Sterilization and working in a clean room environment would be advantageous.
• Thorough knowledge of sterilization and microbiology requirements for terminally sterilized medical devices including ISO 11137, ISO 11737, ISO 14644, FDA and EUMDR requirements along with other relevant standards
• Proven ability of working in a cross-functional team environment
• Excellent interpersonal and communication skills and high level of computer literacy