OverviewThe Project / Equipment Engineer reports to the Senior Manager for Strategic Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Filter/Filter Integrity Testing areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs. This is a 12 Month Contract opportunity with potential to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more.Key ResponsibilitiesProject management and execution of assigned projects including project prioritization, resources management, status management and external communication.Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operation.Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up.Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment.Ability to translate strategic/emerging technology solutions into pragmatic executable plans.Development and management of change controls.Participate as a member of multidisciplinary site and multisite teams.Development of detailed specifications, engineering documents, protocols and standard operating procedures.Work in a collaborative manner within the Process Teams structure and contribute to Root Cause Investigations and Cross Functional Investigations.Work with System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrades and/or retrofits.Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies and procedures.Support a safe working environment by complying with environmental health/safety practices, rules and regulations.Travel may be required to support execution of projects.Experience and QualificationsBachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience.Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly.Strong mechanical capability with hands on experience in a technical role within a high-volume manufacturing environment, is advantageous.Demonstrated experience in a GDP Compliant environment.Experience in MS Office, MS Project, Change Control & Document Management Systems.Proven ability working cross functionally, delivering technical solutions and implementing improvements.Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results.Technical report writing and communication/presentation skills.Seniority levelMid-Senior levelEmployment typeContractIndustriesPharmaceutical ManufacturingNotes: The listing originally included multiple unrelated postings and timestamps from the job board. This refined version retains the core job information and removes extraneous content.
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