This is an 11 month contract
To provides in-line technical support to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role is responsible for all aspects of method and equipment validation in the microbiology department assisting in the effective and efficient running of the method and equipment validation programs. In addition, providing on-going technical support to the site in microbiology and contamination control. The ideal candidate will demonstrate a high level of leadership, collaboration, and coaching to facilitate the team in becoming a high-performance organization. Central to this objective will be the active engagement and communication with all internal (e.g. QC Analytical, Tech Ops, IPT, QA) and external (e.g. Microbiology COE) stakeholders. A high level of innovation, enthusiasm and drive will be required to deliver technical excellence in analytical microbiology related methods.
• Technical support and provision of technical leadership in microbiology to other area personnel
• Development of Microbiological methods, Method Validation and Method Qualification, mainly bioburden, endotoxin, and Sterility test methods
• Analytical Method Transfer and Qualification
• Approval of procedures, protocols, reports and other GMP documents as required
• Performance, design and direction of bench experiments for validation purposes
• Troubleshooting of issues which arise during the execution of validation studies and routine tests.
• Microbiology Support to Site Investigations
• Driving Continuous Improvement initiatives, including lean lab initiatives, method
• Participation in Specifications Development as required
• Laboratory Equipment Qualification / Risk Reduction
• Procedural updates
• General Analytical Support to Quality Control Laboratories
• Supporting the environmental control program by trend analysis and
implementation of appropriate corrective and preventative measures.
• Troubleshooting of suspected Microbiological Contamination events
• Acts as a resource to colleagues with less experience in Microbiology.
• Leads analytical microbiology project improvement teams.
• Coaches and guides colleagues within the site and in the network on analytical microbiology.
• Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Assessing compendial and regulatory updates in regard to the area of Microbiology and Laboratories.
• Interprets customer needs, assesses requirements, and identifies solutions to nonstandard requests.
• Makes decisions within guidelines and policies which impact microbiology projects.
• Liaises with the global Microbiology Network to ensure alignment on actions related to the relevant Quality bulletin/QMS and regulatory changes.
• Works with sister and other sites to aid them in Microbiology related topics, as required.
• Ensure highest safety standards.
• May be required to perform other duties as assigned
• Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
•Demonstrated change management skills (CEM) with continuous improvement.
• Demonstrated knowledge in microbiology related test methods i.e. Bioburden,Endotoxin and Sterility testing.
• The ideal candidate will have at least 7 years’ experience in the pharmaceutical industry or a similar operating environment which includes a minimum of 3 years experience in a Microbiology function.
• Knowledge and experience in interpreting current applicable regulatory
requirements and providing independent support to the site
• Demonstrated ability to work independently and fully realize improvement initiatives with minimal guidance
• Demonstrated ability to drive the completion of tasks
• Demonstrated delivery of SME knowledge above site
• Demonstrated successes in a team environment, such as project teams, Six Sigma team etc.
• Advanced PC skills such as Excel, Word, PowerPoint
• Demonstrated ability to clarify, communicate and solve complex problems and responsibility
• Highly motivated and interested in bringing current microbiology research and
technology platforms toward a biopharmaceutical operations application
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