The Project engineer within the Strategic Projects group and is responsible for the scoping and execution of projects supporting Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Inspection, Component Preparation and Packaging areas. This includes implementation of maintenance programs associated with the introduction of new equipment.
* Project management and execution of assigned projects including project prioritization, resources management, status management and external communication.
* Working with various stakeholders, to scope the project and ensure the requirements are satisfied. Project input will span from concept, through design and on to construction, commissioning and operation
* Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues during start-up and qualification.
* Development and implementation of maintenance programs associated and spare parts inventory optimization with the introduction of new equipment.
* Ability to translate strategic opportunities and emerging technology solutions into tangible 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
* Works in a collaborative manner within the Process Teams structure and contributes to investigations, Cross Functional Investigations etc.
* Works in a collaborative manner with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers and Vendors to perform equipment upgrade 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 all pertinent environmental health/safety practice, rules and regulations
* Bachelors degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience
* Typically 4+ years engineering experience, preferably in the biotechnology/bio-processing industry
* Demonstrated experience in a GDP Compliant environment.
* Experience in MS Office, MS Project, Change Control & Document Management Systems
* Proven ability around working cross functionally, delivering technical solutions and identifying improvements.
* Solid leadership, technical writing, and communication/presentation skills
* Experience working in a self-managed work team, embracing an interdependent working culture that delivers results
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