Process Microbiologist

CPL

Cork

This position is responsible for providing technical support to QC and Process Microbiological activities.Plays a lead role in Contamination Control for Operations. The key functions of the Process Microbiologist role are (a) investigations and risk assessment (b) environmental monitoring oversight (c) review and define specific techniques for critical process steps (d) training design and delivery. The role should Provide technical assistance to QC Analysts and to Operations to ensure business, quality and compliance goals are met. The Process Microbiologist is a critical resource and must have a clear succession plan. Duties and Responsibilities. • Actively supports Process microbiological investigations. • Maintain, re-evaluate and communicate key critical inputs to site. Environmental monitoring programme. • Perform Risk Assessments for projects and business innovation initiatives from a microbiological perspective. • Drives strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene. • Defines specific aseptic techniques to be performed for crucial process steps and provides meaningful input to processing operations. • Identifies risks and opportunities in relation to contamination control on the. shop floor and drives follow up initiatives for improvement in close cooperation with operators, QC and operations management. • Play a lead and proactive role in the design, maintenance and delivery of Operations aseptic technique and microbiology awareness training programme. In conjunction with manufacturing help improve training related to microbiological hygiene and contamination prevention. Standard Operating Procedure. • Periodic review of site trends (Utilities) and support identification of appropriate corrective and preventative actions as required. (I.e. critical utilities team. • Provides effective and timely communication to all levels in the organization. as appropriate. • Achieves goals through actively working with departments and individuals involved and being customer -focused while maintaining a focus on the business requirements. • Collaborates with Process Microbiologists across the LM network and the. Microbiological Review Comittee. SIGNIFICANT SAFETY OR WORKING CONSIDERATIONS: All employees are required to comply with the requirements of the company’s Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act (2005), all employees are required to: • Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions. • Comply with EHS rules and procedures at all times. • Understand the potential EHS impact of their activities. • Attend and participate in EHS training as required. • Use PPE and safety equipment as required. • Report all incidents, accidents, and near miss events. • Report unsafe plant, equipment, acts, procedures or issues. QUALIFICATIONS AND EXPERIENCE- ESSENTIAL. • BSc in a scientific/technical discipline required. • A minimum of 5 years’ experience within the biological and/or pharmaceutical industry. • Possesses deatiled knowledge of routine and non-routine testing and sampling methods, techniques and related equipment. • Possess a detailed knowledge of the shop floor manufacturing process. • Possess a comprehensive knowledge of trending using statistical analysis. • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. QUALIFICATIONS AND EXPERIENCE- DESIREABLE. • Business Excellence and Problem Solving skills Qualifications e.g. Six Sigma, Lean Green Belt , Event Mapping or Kepner-Tregoe analysis. • Train the Trainer Qualification. If you are interested in this role contact me for a more information. This job originally appeared on RecruitIreland.com.

2801 days ago