Company Microbiologist

Sigmar Recruitment; Dublin; Presencial; EUR 80.000 - 105.000; Jornada completa

Descripción de la vacante

Sigmar Recruitment is seeking an experienced Microbiology and Sterilization Specialist for our Dun Laoghaire site. You will ensure compliance with regulatory and company standards, maintain inspection readiness, and provide subject matter expertise across ETO sterilization, GLP practices, and cleanroom operations.

You will support microbiology testing, environmental monitoring, and non-conformance investigations, while collaborating with cross-functional teams to uphold quality and regulatory

Formación

• Degree in Microbiology or related science.
• Experience in medical devices/pharma/biotech sectors preferred.
• Strong knowledge of GLP, ISO 13485 and sterilization standards.

Responsabilidades

• Ensure compliance with microbiology, sterilization, GLP and cleanroom requirements.
• Provide technical microbiology and sterilization expertise.
• Review sterilization cycles and data for lot release.
• Lead or support root-cause investigations of non-conformances.
• Maintain audit and inspection readiness for internal/external/regulatory bodies.
• Support site safety, equipment readiness and data integrity.

Conocimientos

Interpersonal skills

Cross-functional teamwork

Analytical skills

CAPA investigations

Computer literacy

Educación

Degree in Microbiology

Descripción del empleo

Responsible for ensuring that products manufactured at the site comply with all microbiological, ETO sterilization, GLP, and cleanroom requirements.

This role provides technical microbiology and sterilization expertise, ensures adherence to regulatory and company standards, and maintains the site in a state of inspection readiness throughout the contract period.

Responsibilities:

• Maintain up-to-date knowledge of all relevant international regulatory requirements related to microbiology, sterilization (including ISO 11135 and ISO 10993), and cleanroom controls applicable to Dun Laoghaire products.
• Maintain up to date knowledge of all relevant international regulatory requirements related to cleanroom operation (including ISO 14644 and ).
• Provide daily technical oversight and subject matter expertise for: ETO sterilization processes; product adoption, full/ reduce sterilization requalification; GLP-compliant laboratory practices; and cleanroom behavior, controls, and environmental monitoring.
• Support Microbiology Technicians in the execution of microbiological testing, environmental monitoring, and sterilization activities.
• Set appropriate microbiological and sterilization quality standards for products and ensure consistent application across the site.
• Ensure full compliance with internal sterilization procedures, cleanroom requirements, GLP expectations, and global Quality System regulations.
• Review sterilization cycles, microbiological data, and processed product lots; approve lots for release in accordance with quality standards.
• Lead or support root cause investigations involving microbiological or sterilization-related non-conformances.
• Act as microbiological and sterilization technical specialist for the Dun Laoghaire site and collaborate with relevant technical specialist groups.
• Support the site in always maintaining audit and inspection readiness (internal, external, Notified Body, and regulatory).
• Maintain laboratory safety, equipment readiness, and compliance with data integrity expectations.
• Perform any other duties as reasonably required by management during the contract period.

Educational Requirements and Relevant Experience:

• Degree in Science or a related Quality discipline, specializing in Microbiology.
• Minimum 5 years’ experience in medical devices, pharmaceutical, or biotech sectors.
• Demonstrated expertise in: ETO sterilization (cycle review, dose audits, standards compliance); GLP principles and laboratory governance; and cleanroom operations and environmental monitoring.
• Experience with process validation, sterilization validation, and cleanroom compliance.
• Radiation or sterilization experience (ISO 11135 / ISO 11137) advantageous.

Knowledge, Skills and Abilities:

• Excellent interpersonal, communication, and team-building skills.
• Proven ability to work within cross-functional teams in a regulated environment.
• Strong understanding of ISO 13485, FDA QSR/QMSR, and sterilization standards.
• Strong analytical and problem-solving skills with experience in investigations and CAPA.
• High level of computer literacy, including Microsoft Office applications.
• Ability to manage complex technical activities independently with minimal supervision.