Senior Project Engineer

: PE Global is currently recruiting for a Senior Project / Equipment Engineer on behalf of a leading biotech company based in Dublin South.
This is an initial 12-month contract role.
Overview: The 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.
Role 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 Skills required: Bachelors 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, 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.
Technical report writing and communication/presentation skills Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application.
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Skills: project management fill finish equipment qualification

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