Description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. Advancing possibilities for a brighter tomorrow We are seeking a  Microbiologist I on a  permanent basis to join our team in our Cork site. Job Purpose: The Microbiologist I is responsible for supporting the Microbiology Laboratory in achieving key Quality, Compliance, and Performance objectives while ensuring adherence to applicable regulatory requirements and company procedures. The role provides technical microbiological expertise, supports laboratory operations, drives continuous improvement initiatives, and contributes to maintaining a compliant and efficient laboratory environment. Key Responsibilities: • Report directly to the Site Microbiologist and support the delivery of key Quality, Compliance, and Performance objectives. • Ensure ongoing compliance with cGMP requirements and applicable regulatory standards, including those of the FDA, TÜV, DEKRA, and other relevant regulatory agencies. • Provide microbiological expertise and guidance to cross-functional teams on topics including regulatory requirements, product bioburden, endotoxin control, contamination control, and microbiological impacts of product or process changes. • Coordinate and support training activities for Laboratory Analysts, promoting a strong culture of quality, compliance, and continuous development. • Ensure compliance with all laboratory procedures, quality system requirements, and relevant site-wide policies and practices. • Lead the introduction of new laboratory equipment, including coordination of qualification activities, change control implementation, and associated documentation. • Prepare for and participate in internal, customer, and regulatory audits, serving as a Subject Matter Expert (SME) for microbiology-related activities. • Conduct daily review of microbiological testing raw data to ensure prompt identification, investigation, and closure of laboratory records, deviations, and related documentation within defined timelines. • Author, revise, review, and approve Standard Operating Procedures (SOPs), laboratory methods, protocols, reports, and other quality documents as required. • Coordinate microbiological validation activities for new products in collaboration with New Product Introduction (NPI) teams to ensure successful implementation with minimal impact to routine commercial testing. • Provide technical leadership and mentorship to Technician I and Technician II personnel while fostering a safe and compliant laboratory environment. • Attend and represent the Microbiology function at cross-functional meetings, project teams, and site initiatives. • Support the Site Microbiologist in ensuring a cost-effective, efficient, and responsive microbiology testing service. • Schedule laboratory testing activities and, in the absence of the Site Microbiologist, oversee the day-to-day operation and management of laboratory activities. • Drive continuous improvement activities that enhance laboratory efficiency, compliance, data integrity, and overall operational effectiveness. • Complete, review, and approve microbiological and laboratory-related non-conformances, deviations, and CAPAs, ensuring timely closure and compliance with site Quality System requirements. Education & Experience: • Minimum 3 years' relevant experience in a GMP-regulated microbiology laboratory, preferably within the medical device, pharmaceutical, or biotechnology industry. • Degree in Microbiology, Biological Sciences, Biomedical Sciences, or a related scientific discipline. • Experience working in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. • Knowledge of microbiological testing methods including bioburden, endotoxin, environmental monitoring, and contamination control. • Understanding of cGMP requirements and medical device regulatory expectations. • Strong technical writing, problem-solving, and organizational skills. • Ability to lead projects, manage multiple priorities, and work effectively within cross-functional teams. • Excellent communication and interpersonal skills. Core Competencies: • Technical Expertise in Microbiology • Regulatory Compliance & Quality Systems • Data Review and Documentation Management • Leadership and Mentoring • Project Management • Continuous Improvement • Audit Readiness & Inspection Support • Problem Solving and Risk Assessment • Collaboration and Stakeholder Engagement As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com