Process & Equipment Engineer
Job Description
My client, an established Biologics manufacturing multinational in South Dublin, is recruiting for a Process & Equipment Engineer to join their team.
The role is a contract position with excellent rates and opportunity for long-term placement.
As a member of the Process & Equipment Engineering team, the role will support complex and challenging manufacturing initiatives.
This is an office hours M-F position and requires experience with syringe filling and packaging machines.
Key Responsibilities:
* Ownership of equipment/systems in a GMP regulated manufacturing setting
* Support Drug Product manufacturing within the Formulation, Vial/Syringe Filling, Lyophilisation, Inspection, Component Preparation and Packaging areas
* Lead and support system improvements, development of detailed specifications, engineering documents and standard operating procedures
* Lead technical root cause analysis, incident investigations and troubleshooting issues related to manufacturing equipment/systems
* Support new product introductions or new technology introductions by performing engineering assessments, implementation of system changes and supporting engineering runs
* Solving complex problems, project management, equipment lifecycle management and operational excellence
* Develop and manage change control requests per established SOPs and processes
* Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
Preferred Qualification
* Bachelors in Engineering (Mechanical, Electrical or Chemical)
* Manufacturing experience in biopharmaceutical Formulation/Fill/Finish or Active Pharmaceutical Ingredient (API) facilities
* Solid leadership, technical writing, and communication/presentation skills
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices
* Experience in developing strategies for new product introduction and new technology deployment
* Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans
* Ability to influence the development of business area strategy and engineering/equipment strategy where appropriate
* Ensure application of corporate blueprint and standards using business drivers to local business needs
* Development and presentation of project plans to senior management
* Day to day vendor management and contract negotiations with focus on equipment suppliers
* Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
* Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
Travel at various times may be required to support execution of projects
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