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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.
Key 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.
Experience and Qualification
* 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.
* 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.
Seniority Level
Mid-Senior level
Employment type
Full-time
Dublin, County Dublin, Ireland
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