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  • DUBLIN 2
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  • Job reference number:15330371
  • Client ID:RI/AM15912
  • Posted on:08-MAR-2018
  • Location:WATERFORD
  • Job type:PERMANENT

Senior Microbiologist - County Waterford.

Job Purpose: To be part of a new Microbiology function in a state of the art start-up Fill-Finish facility. Introducing methods, practices and procedures to both QC and production and ensuring aseptic and sterility assurances principle are implemented and maintained from project phase to routine operation.


1. Health, Safety and the Environment
a. Comply with legislative requirements for construction projects.
b. Comply at all times with Health, Safety and Environmental policy and procedure.
c. Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.

2. Quality Compliance
a. Ensure all work is carried out in compliance with GMP, GLP and regulatory standards and guidance.
b. Ensure all work is documented in accordance with the highest GMP standards including maintenance of data integrity at all times.

3. Laboratory
a. Introduction and validation of all Microbiology methods in-house including but not limited to Environmental Monitoring, Identifications, Growth Promotion, Sterility, Endotoxin (rapid method), Microbial Limit Testing, Biological Indicators
b. Reading of plates, data review, trending.
c. Assessment of trends and communication of findings to other departments.
d. Raising and investigation of out of specification results.
e. Management of projects and testing contracted to external laboratories.
f. Performance of laboratory sampling and testing.

4. Production
a. Provide technical knowledge and guidance on aseptic assurance, sterility assurance and trending as applicable to the production environment for the duration of the project and during routine operation
b. Participate in Operational Readiness for the duration of the project.
c. Participate in risk assessments as a Subject Matter Expert (SME).
d. Provide oversight during Media Fills.
e. Provide support during production investigations.

5. Delegation
a. Provide support and back up to the Microbiology Manager and take on delegated tasks/projects as required.

Minimum Qualifications & Experience Sought:

1. Qualified to a minimum of Degree level in Microbiology or Biological Sciences
2. Demonstrated experience in providing Microbiological support to a production facility
3. Demonstrated ability to introduce, validate and optimise QC methods
4. Demonstrated application of appropriate regulatory standards and previous participation in regulatory audits an advantage.
5. Experience working in a cross-functional team environment

6. Strong technical knowledge of Microbiology as it applies to both QC and Fill Finish facilities
7. Ability to implement cGMP and GLP
8. Thorough understanding of Method Validation as it applies to Microbiology
9. Ability to manage multiple conflicting demands and to prioritise accordingly

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