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Vacancy Details

Science Pharmaceutical and Food

106587 - Process Microbiologist - Sterile Fill Finish - Cork

Contract Type: Permanent
Location: Cork
Date: 16/01/2020
Job Reference: 106587
Contact Name: Clara Burke
Contact Email:

Job Description

Process Microbiologist - Sterile Fill Finish - Cork - 106587
Process Microbiologist - Sterile Fill Finish - Cork
The Process Microbiologist will join a growing fill finish project team to provide technical microbial process support and expertise to the team to meet our company’s Priorities of: Compliance, Supply, Strategy and Profit Plan.

The working style is one of collaboration, coaching and facilitation to provide technical solutions to the team to support a High Performance Organisation.

The Process Microbiologist is accountable for supporting all technical components of the aseptic process to deliver an effective and efficient Environmental Performance for the project.
  • Provide aseptic guidance on facility and process-related controls and changes.
  • Provide key technical input during the project design and execution stage, ensuring all equipment design meets the requirements and expectations of regulator guidelines
  • Has expertise on Analytical Microbiology Requirements and Systems
  • Handling of non-conforming EM/PM results, trend analysis, APR inclusion
  • Troubleshooting of suspected Microbiological Contamination incidents
  • EM Lead for internal and external audits.
  • Provide ongoing coaching and support to the team members, to share their aseptic technical knowledge and promote best practices.
  • Education and communication of personnel in Aseptic techniques, GMP requirements and regulations
  • Collaborate in the development and execution of the Facility-based Environmental Monitoring programs for a facility upgrade.
  • Process microbiology representative for Facility and Equipment Qualification Requirements
  • Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CAPA's etc.
  • Ensure the highest Quality, Compliance and Safety standards.
  • Represent the IPT and Site on Global cross functional forums.
  • Participate and ensures compliance with our manufacturing division Quality Management System (QMS) requirements, including ownership, as relevant.

The Process Microbiologist will
  • Provide support, guidance and expertise to ensure the success of the project
  • Ensure compliance to all regulatory and our company’s Guidelines.
  • Own the EM governance program utilizing QRM principles to ensure compliance.
  • Model our company’s Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.

  • Third level qualification in Microbiology (Masters preferred)
  • A minimum of 5 years Operations/Quality Control Microbiology experience in a pharmaceutical environment
  • Strong working knowledge of regulatory expectations of process microbiology in the Highly Regulated Pharmaceutical industry.
  • Working knowledge of regulatory expectations of Aseptic processing in Sterile Drug Product.
  • Strong analytical and technical skills.
  • Demonstrated leadership and change management skills with a continuous improvement focus.
  • Knowledge of and experience in applying Six Sigma and Lean methodologies
  • Evidence of Continuous Professional Development
  • Demonstrated high level of problem solving and facilitation skills – resolution and prevention measures.
  • Highly motivated and interested in bringing current microbiology research and technology platforms toward a biopharmaceutical operations application.
  • Demonstrated self-motivation/direction skills with a continuous improvement focus.
  • Demonstrated ability to lead and realise improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
  • Coaching to facilitate the team into becoming a high performing organization
  • Ability to build and fostering relationships with stakeholders.

For further information on this Process Microbiologist role in Cork please contact Clara Burke on 086 8168273 /

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