Company Microbiologist

embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com or follow our social channels on LinkedIn, Facebook, Instagram and X. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day.You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees.embecta is seeking a seasoned microbiology and sterilization expert to lead sterility assurance at our Dun Laoghaire manufacturing site. This strategic role ensures that all products meet global microbiological and sterilization standards, safeguarding patient safety and regulatory compliance. You will lead lab operations, drive validation programs, and serve as the site’s technical authority in audits and cross-functional initiatives.ResponsibilitiesOwn and lead the microbiology laboratory operations, ensuring timely and accurate testing, equipment maintenance, and compliance with global standards.Establish and implement microbiological quality standards for all products, ensuring alignment with sterilization and environmental monitoring requirements.Drive radiation sterilization validation and routine monitoring programs in collaboration with cross-functional teams.Oversee and approve site-wide sterility assurance programs including dose establishment, bioburden testing, sterility testing, endotoxin testing, and environmental monitoring.Conduct risk assessments to support sterility assurance activities and contribute to the site change control program.Lead investigations into sterility assurance and microbiology-related out-of-specification results, non-conformances, and CAPAs.Manage the sterilization product release program for all products manufactured at the Dun Laoghaire site.Serve as the recognized subject matter expert (SME) for microbiology and sterilization, representing the site in internal and external audits.Act as an internal auditor supporting the site’s internal audit program.Collaborate with embecta’s global technical specialist groups to align site practices with international standards and drive innovation.Lead the validation and maintenance of environmental monitoring programs and controlled manufacturing areas.Mentor and develop microbiology personnel, fostering a culture of scientific excellence and continuous improvement.Perform any other reasonable duties as required by management.Education & ExperienceBachelor’s degree in Science or a related Quality discipline with specialization in Microbiology.8+ years’ experience in a microbiology or sterility assurance role within medical devices, pharmaceutical, biologics or food manufacturing.Expertise in radiation and terminal sterilization processes is highly desirable.Thorough knowledge of ISO 11137, ISO 11737, ISO 14644, FDA, EUMDR, and other relevant standards.Experience in process validation, sterilization, and clean room operations.Strong interpersonal, communication, and team-building skills.High level of computer literacy, including proficiency in Microsoft Office applications.Demonstrated ability to work effectively in cross-functional teams and global collaborations.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.