Project Engineer

Summary:
Our client is a global biopharmaceutical company based in south Dublin looking for a Project Engineer for the Capital Projects group. The successful candidate will be responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, Lyophilisation, Device Assembly, Inspection, Labelling and Packaging areas. This includes qualification of new equipment and implementation of associated reliability and maintenance programs..

Responsibilities:

• 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 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 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.

Qualifications & Experience:

• Bachelor’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, Labelling and Ancillary processes.
• 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.
• Technical report writing and communication/presentation skills.
• Data driven decision maker.