Req ID: 127993 Remote Position: No Region: Europe Country: Ireland State/Province: Galway City: Galway **General Overview** **Functional Area:** OPS - Operations **Career Stream:** QUA - Quality **Role:** Associate **SAP Short Name:** ASS **Job Title:** Quality Associate **Job Code:** AST-OPS-QUA **Job Level:** Band 06 **Profile-Holding:** Y **Direct/Indirect Indicator:** Indirect **Summary** We are currently recruiting for a Microbiology analyst to be part of a new product introduction in Galway. By Joining Celestica Galway (Ireland) as a Microbiologist Analyst you will have the opportunity to work on delivering a fully automated high volume manufacturing line from development stage to full scale production ramp producing world class medical devices in a dynamic, fast moving environment. A career at Celestica is only for those who want to do something extraordinary with a meaningful purpose: imagine, develop and deliver a better future with our customers. Celestica is a leader in high – reliability design, manufacturing and supply chain solutions that bring global expertise to every stage of product development. Join us in Galway, Ireland, to contribute to extraordinary advancements in the Med Tech sector. See job description below Your next challenge will be… To maintain high – quality standards in a dynamic laboratory environment. **Detailed Description** Your day to day activities will include the following…  Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards.  Monitoring of utilities including all grades of water, and where necessary, compressed air.  Co-ordination of samples for bioburden and endotoxin testing.  Ordering consumables (media etc) and general stock for day-to-day running of laboratory.  Applying cGLP to all laboratory activities including stock control.  Performing sampling for validations and re-qualifications as required. Review of validation files for compliance.  Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.  Leading NC and CAPA generation and resolution within the Microbiology group and across related business units.  Performing sterility release review, interpreting data and trends.  Identifying opportunity for stabilization of trends, statistical control of processes to allow cost saving.  Mentoring and training team and cross functional groups as required (induction, GMP etc)  Contributing to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.  Coaching, mentoring and training other functions in area of sterility and monitoring. What do we offer:  Market-competitive total reward: flexible salary, fix and variable salary based on goals  The opportunity to become a key member of the new product introduction team in the Health Tech Quality function driven by innovation where creativity matters.  Training and development opportunities, with us the sky is the limit!  The opportunity to innovate, learn, mentor others and work toward your own vision of career success  A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities  A sustainable culture where we provide opportunities for employees to give back to the community. **Knowledge/Skills/Competencies** What do we expect from you?  Strong knowledge of quality tools, QSR, ISO/MDR standards, and processes.  Strong interactions, maintenance and support of sterility suppliers  Strong competency in troubleshooting, correction of NC and root cause analysis.  Effective communication, project management, and influencing skills.  Strong analytical and critical thinking skills.  Thorough working knowledge of sterilization processes, validation techniques, and cleanroom monitoring/standards.  Experience in working independently in compliance risk situations. **Physical Demands** + Duties of this position are performed in a normal office environment. + Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data. + Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required. **Typical Experience** What are we looking for?  Bachelor’s degree of Microbiology or equivalent.  2+ years of Sterilization/Microbiology engineering experience preferred.  Openness to short-term travel assignments, especially in the early project stages.  Experience in the Medical Device industry or another highly regulated environment.  Familiarity with 6 Sigma quality methods is advantageous. **Typical Education** + Bachelor's degree in related field, or consideration of an equivalent combination of education and experience. + Educational requirements may vary by geography. **Notes** This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time. Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them. **COMPANY OVERVIEW:** Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers. Celestica would like to thank all applicants, however, only qualified applicants will be contacted. Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.