MidFull TimeTemporaryContract
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.
Job Purpose:
Responsible for ensuring that products manufactured at the Dun Laoghaire 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 <USP 1116>).
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: GLP principles and laboratory governance; cleanroom operations and environmental monitoring.
Experience with process validation and cleanroom compliance.
Terminal Sterilization/Ethylene Oxide Sterilization and ISO 11135 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.
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.
