Microbiologist

Microbiologist required by our client, a Multinational biopharmaceutical company based in Waterford City focused on improving patients’ lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs. The company has a portfolio of medicines through its orphan and inflammation groups.
The Overall purpose of this position is to be part of a new Microbiology function in a state of the art start up Fill Finish facility. Assisting the introduction of methods, practices and procedures to both QC and production and helping to ensure aseptic and sterility assurances principle are implemented and maintained from project phase to routine operation.
Responsibilities
1. Health, Safety and the Environment
  • Comply with legislative requirements for construction projects.
  • Comply at all times with Health, Safety and Environmental policy and procedure.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
2. Quality Compliance
  • Ensure all work is carried out in compliance with GMP, GLP and regulatory standards and guidance.
  • Ensure all work is documented in accordance with the highest GMP standards including maintenance of data integrity at all times.
3. Laboratory
  • Assist with 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
  • Reading of plates, data review, trending.
  • Assessment of trends and communication of findings to other departments.
  • Investigating of out of specification results.
  • Performance of laboratory sampling and testing.
4. Production
  • 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
  • Participate in Operational Readiness for the duration of the project.
  • Participate in risk assessments as required.
  • Assist in the provision of oversight during Media Fills.
  • Provide support during production investigations.
5. Delegation
Qualifications
  • Provide support and back up to the Senior Microbiologist and take on delegated tasks/projects as required.
  • Qualified to a minimum of Degree level in Microbiology or Biological Sciences
  • Strong technical knowledge of Microbiology methods and application
  • Demonstrated interest in the application of Microbiology principles to industrial settings.
  • Demonstrated ability in the performance of QC Microbiology methods (in industry or other settings including college projects)
  • Awareness of regulatory standards and how they apply to Pharmaceutical Microbiology
  • Experience working in a cross functional team environment Awareness of cGMP and GLP standards
Behavioural & Competencies Skills
  • Flexibility and ability to manage time and conflicting priorities
  • Positive and enthusiastic attitude
  • Ability to form strong relationships cross functionally
  • Dynamic and is motivated by projects and common goals
  • Inquiring and enjoys gaining knowledge and solving problems