Kelly Services are recruiting for a Senior Project Engineer on a temporary basis for 12 month with a Dublin based pharmaceutical company. 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, Labelling and Packaging 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, 5+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Ancillary processes.90
* Process development or 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
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.
