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 / email@example.com
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