* Execute and drive new Laboratory Instrumentation/Equipment procurement projects up to Performance qualification stage to meet required timelines.
* Author or peer review instrumentation lifecycle, commissioning and qualification documents.
* Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues for all laboratory equipment and systems including Empower and LIMS.
* Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and procedures for various systems; ensure all work is subsequently carried out in line with same.
* Attend / Facilitate the laboratory systems and instrumentation daily team meeting and other cross functional forums as required.
* Ensures all routine and non-routine Laboratory system equipment maintenance is completed as required. Ensures instrumentation projects, PM's and Calibrations are performed to meet the laboratory testing schedules.
* Liaise with vendors and outsourced providers for instrumentation calibration and maintenance.
* Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc, all under aseptic/clean room conditions. Provide input, review and approval for atypical, observation, and process capability investigations. Oversee coordination of resources to implement suggestions/ideas of merit. On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systems.
* Participate in the generation and update of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications
* Contribute to the achievements of department productivity and quality goals
* 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.
* Third level qualification (Degree) in a science related discipline, ideally in Chemistry or Analytical Chemistry.
* 5 years of experience in a senior laboratory role in a pharmaceutical Laboratory
* Considerable experience and technical troubleshooting skills, particularly with analytical equipment performance.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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The Life Science Specialists