Microbiologist - 12 Month FTC

Company Overview

embecta is a global diabetes care company that leverages its 100 year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions and partnerships.

Job Summary

We are seeking an experienced Microbiology / Sterilization professional to join our DunLaoghaire manufacturing site. In this role, you will be the site subject matter expert for microbiology, ETO sterilization, GLP, and cleanroom standards, ensuring all products are manufactured in full compliance with regulatory and company requirements.

Responsibilities

• Maintain up to date knowledge of all relevant international regulatory requirements related to microbiology, sterilization (including ISO11135 and ISO10993), and cleanroom controls applicable to DunLaoghaire products.
• Maintain up to date knowledge of all relevant international regulatory requirements related to cleanroom operation (including ISO14644 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 DunLaoghaire 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 five years' experience in medical devices, pharmaceutical, or biotech sectors.
• Demonstrated expertise in GLP principles and laboratory governance; cleanroom operations and environmental monitoring.
• Experience with process validation and cleanroom compliance.
• Terminal Sterilization/Ethylene Oxide Sterilization and ISO11135 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 ISO13485, 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.

Equal Opportunity Statement

embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.