At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
The Site Microbiologist is responsible for the micro/bioburden and environmental monitoring (EM) management program in Jabil Waterford. The main duties of the role include performing monthly environmental monitoring in accordance with cGMP principles, managing micro excursion events internally and with the customer, micro data analysis and reporting as well as supporting and leading GMP training activities in relation to bioburden. Acts as Jabil Waterford’s quality contact for all micro/bioburden issues at the site.
Key Responsibilities and End Results : (Essential responsibilities include but are not limited to the following):
· Creates/maintains all site procedures in relation to micro/EM
· Understands and executes risk management practices in relation to EM
· Identifies, investigates and manages the resolution of excursions in bioburden/micro at the site
· Proactive in the prevention of excursions in bioburden/micro at the site
· Communicate excursions in bioburden/micro to the site Quality Lead.
· Generates annual EM summary report
· Exposure and involvement in supporting the CAPA system
· Complete appropriate reports in relation to microbiology activity performed at the site
· Support the company with internal and external audits
· Develop and manage microbiological and cleanroom GMP requirements within the manufacturing site
· Liaises with suppliers on their bioburden controls
· Acts as the Jabil lead for customer issues on bioburden
· Acts as chief auditee on all external audits in relation to EM and site contamination control strategy
· Contributes to the GMP training program and delivers training as appropriate for bioburden
· Ensure the quality and production documentation is suitable in design for bioburden control
· Review and sign off of annual validation report of the cleanroom
· Contributing to the design and layout of the cleanroom for bioburden control
· Responsible for the setting, maintaining and implementing hygiene management systems of the cleanrooms
· Support the quality function where necessary.
· Supports all company Lean Manufacturing principles
· Ensures compliance with all company policies and practices in areas such as safety and all regulatory
· Supports all company quality programs and initiatives
· Ensure ongoing compliance with GMP in all practices, recording of events and processes
· Ensure compliance with all learnings from all GMP training events
· Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position
· BSc Degree in Microbiology (or similar) discipline.
· Several year’s experience in a microbiology applied role (preferably Medical Device/Pharmaceuticals
Skills and Attributes:
· Organisational and planning skills are required to plan, execute and track quality commitments
· Working knowledge of ISO 13485 &/or Pharmaceutical EU GMP (Eudralex Volume 4)
· Excellent accuracy and attention to detail
· Excellent IT, communication and interpersonal skills to communicate well, both verbally and in writing.
· Ability to work on own initiative and as part of a cross functional team
· Desire to learn new tasks and flexibility
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.
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