Microbiology Technical Specialist
Tandem Project Management
- Co Meath
- Contract
- Full-time
Our client, a biopharmaceutical company located in Meath, is searching for a Microbiology Technical Specialist. The ideal candidate will organise, schedule and coordinate routine day-to-day laboratory operations and Microbiology validation activities. Provide technical oversight and supervise laboratory testing/ review activities. Liaise with laboratory customers to ensure customer demands can be met as required. The ideal candidate will also provide technical expertise, troubleshooting, training and support to laboratory technicians and ensure that objectives are effectively achieved, consistent with our client’s requirements to ensure compliance, safety and reliable supply customers.Responsibilities:
- 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.
- Drive Continuous Improvement in the lab including implementation of lean projects.
- 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.
- Bachelor's Degree or higher preferred; ideally in Microbiology or a closely related discipline.
- Minimum 8 years' experience in the Microbiology Pharmaceutical industry or a similar operating environment.
- 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.
- Investigation experience.
- Demonstrated project work.