• The Microbiologist Quality Engineer is responsible for the micro/bioburden and environmental monitoring (EM) management program in Jabil Waterford.
• An Individual with an experienced background in manufacturing within controlled environments. 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.
• Develops and implements all micro procedures using micro statistics, lean manufacturing concepts and analyses.  Ensures that established company, customer and regulatory requirements are maintained across the site.  Reviews, Analyses and reports on micro contamination discrepancies related to site process. Supports all Jabil Waterford micro/bioburden investigations on site. Investigates problems and recommend modification and corrective action for recurring or non-recurring discrepancies. 

• Interfaces with manufacturing, suppliers, vendor and subcontractor representatives to ensure requirements are met.
• 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 relevant site procedures to ensure accuracy.
• Execution of viable and non-viable particle counts.
• Execution of Environmental Monitoring across the site.
• Co-ordination and approval of viable and non viable particle counts.
• Owns and maintains risk management practices in relation in accordance with !SO14971 and EU GMP ICH Q9.
• Identifies, investigates and manages the resolution of excursions in bioburden/micro at the site.
• Ensures mitigation of excursions in bioburden/micro at the site.
• Communicate excursions in bioburden/micro to the site Quality Lead.
• Generates annual EM summary report.
• Follow and maintain timely execution of Micro schedules.
• Supports the CAPA system by leading and coordinating all Micro related CAPAs.
• Complete appropriate reports in relation to microbiology activity performed at the site.
• Supports and executes Internal audits as part of the sites internal audit schedule and acts as chief auditee on all external audits in relation to EM and site contamination control risk strategy.
• Develop and manage microbiological and cleanroom GMP requirements within the manufacturing site.
• Bench marks the site with national and international practice to ensure alignment with up to date and current practice.
• Liaises with suppliers on their bioburden controls.
• Sample preparation for external service providers and contract test labs.
• Acts as Jabil Waterford’s quality contact for all micro/bioburden issues at the site.
• Owns and maintains the contamination control risk strategy for Jabil Waterford.
• Contributes to the GMP training program and responsible for the delivery of training as appropriate for bioburden.
• Influences and establishes cross functional teams to ensure the quality and production documentation is suitable in design for bioburden control.
• Work cross functionally with other departments, to provide and drive micro/contamination standards into the overall operational activities of the company.
• Provides staff with development opportunities & coaching; sets appropriate standards of behaviour.
• 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 compliance.
• Ensures site practice is up to date and aligned with current regulatory and industry standards.
• 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.
• Aligning customer specification to JABIL capabilities.
• 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.
• Individual shall have exposure & involvement in both supporting and having oversight of parts of the CAPA system as assigned.
• Support and lead Key aspects of the QMS including (as assigned):

       -Change Control

       -Non Conforming Events

       -Deviations

        -CAPA (Corrective Actions, Supplier Corrective Actions, Customer Complaints

• Support Corporate initiative in relation to changes/improvements /alignment to corporate QMS.
• Application of risk management principles in accordance with !SO14971 and EU GMP ICH Q9
• Individual to use initiative to drive continuous improvement projects in areas of the QMS/Workcell.
• Uses scrap reduction methodology and process capability analysis to provide a robust defect free process.
• Individual shall support the external and internal Quality Management System auditing function(Lead auditor Training)
• Close liaison and networking with other departments to provide and drive quality inputs and initiatives into the overall operational activities of the company.

Job Specifications: The minimum education and experience required to perform this job competently.   

• BSc Degree in Microbiology/Pharmaceutical Science or equivalent discipline.
• Two years experience in applied role (preferably Medical Device/Pharmaceuticals manufacturing).
• Fully competent in Iso 13485/14644 Micro Standards and Pharmaceutical EU GMP (Eudralex Vol 4).

Skills and Attributes:

• Organizational and planning skills are required to plan, execute and track quality commitments.
• Fully competent in Iso 13485/14644 Micro Standards and Pharmaceutical EU GMP (Eudralex Vol 4).
• Individual with an experienced background in bioburden standards, requirements and implementation.
• Individual with an experienced background in environmental monitoring and control of manufacturing environments.
• Training and understanding of GLP practices.
• Organizational and planning skills are required to plan, execute and track micro commitments.
• Excellent accuracy and attention to detail.
• Excellent organization, communication, computer & presentation skills.
• Excellent IT, communication and interpersonal skills to communicate well, both verbally and in writing.
• Excellent initiative, decision making and be able to work in a core team environment.
• Solution driven with emphasis on performance and results.
• 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, age, disability, genetic information, veteran status, or any other characteristic protected by law.

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