Dún Laoghaire, IRL
1 day ago
Project/Equipment Engineer
The Project / Equipment Engineer reports to the Senior Manager for Facilities & Engineering Projects and is responsible for portfolio ownership, scoping and executing technical projects within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation and inspection areas. This includes new product introductions, qualification of new equipment and implementation of associated reliability and maintenance programs. Key Responsibilities • Portfolio ownership of a number of projects within a specific business area supported by reporting engineers for successful completion. • Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up • Coordination of engineering readiness scoping and readiness for new product introductions. • Project 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 commercial operational readiness. • 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 contributes to Root Cause Investigations and Cross Functional Investigations. • 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 environmental health/safety practice, rules and regulations • Travel may be required to support execution of projects. Experience and Qualification: • Bachelor’s Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience • Typically, 5+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes. • Device assembly / Packaging Experience preferred. • Technology transfer experience preferred. • Proven project management experience. • 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 • Data driven decision maker • Ability to work to tight deadlines in a fast-moving environment.
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