Microbiology Specialist - Dunboyne - 12 month Maternity Cover
Eurofins
- Dunboyne, Co Meath
- Permanent
- Full-time
- Developmental opportunities and career progression
- The opportunity to work with our client - a world -leading pharmaceutical and biotechnology company
- Location is easily accessible
- Private Medical Insurance
- Income protection and life assurance
- Annual discretionary bonus
- Free parking onsite
- Full use of the canteen facilities on the client site
- Additional annual leave days with continued service
- The opportunity to work on therapeutic drugs helping to save lives across the world
- Operate as part of self-directed work team in allocating testing and assigning tasks based on priorities, including daily, weekly, monthly and quarterly tasks. Perform tasks with a high degree of precision and accuracy and ensure others do likewise.
- Liaise effectively with external groups such as Manufacturing, Tech Ops, CQV, Plant Engineering and QA to ensure laboratory support is available as required and testing timelines are met.
- Ensure adherence to lab testing schedules, applying Lean Lab methodology.
- Ensures testing/data review are supported and that results are available within lead times to laboratory customers. Anticipated delays should be escalated, with proposed solutions for resolution.
- Ensures projects are supported and completed as per project timelines. Anticipated delays should be escalated, with proposed solutions for resolution.
- Author/provide leadership in the Laboratory/Contamination investigations using own initiative and with minimum supervision.
- Coach and mentor the Laboratory Team.
- Work as directed by according to Company safety policies, cGMP and cGLP.
- Facilitate and drive effective communication to ensure success.
- Ensure the Lab Tier/handovers are facilitated, and attendance expectations are met.
- Provide support with audit/inspection requirements to ensure department compliance/readiness.
- Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
- Development and execution of Microbiology test methods, Method Validation and Method Qualification.
- Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
- Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
- Ensure that the customer gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
- A degree in Microbiology or a related discipline is required with a minimum of 6 years' within a pharmaceutical regulatory environment.
- At least 8 years' experience in an GMP environment, preferably within QC microbiology department.
- Strong knowledge in microbiology related lab test method methods e.g. Environmental Monitoring, Microbial Identifications, Bioburden testing, Endotoxin testing, Biological Indicator Testing, Absence of Contamination Testing (BacT), Growth Promotion/Sterility Testing.
- Experience with New Product Introduction and Microbiology Method Validation experience.
- Deep understanding of data integrity and the importance of adopting this guidance when reporting results / everyday work.
- Is proficient in the use of numerous laboratory instruments, software packages and other analytical techniques.
- Is proficient in problem solving and may have expertise in troubleshooting laboratory equipment.
- Thorough understanding of requirements for working in a GMP environment.
- Ability to quickly learn new processes.
- Ability to communicate clearly and to form strong working relationships with colleagues.
- Ability to work on own initiative and be capable of developing solutions to problems as part of a team.
- Willing to operate in a flexible manner and be able to switch priorities at short notice.
- Good team player, organised, accurate, have strong documentation skills.
- Passionate about quality and customer service.
- Good communication skills both internally and externally and avoids making mistakes that will hinder the understanding of his/her written and verbal exchanges.