Are you a senior validation engineer looking for a new opportunity in Limerick, Ireland? Do you have experiences in a manufacturing environment within the life sciences industry? Are you interested in joining a global leader in medical technologies? If you are interested in progressing your career in life sciences and becoming part of patient and healthcare outcomes, don't hesitate and apply today!
Job Description
The senior Engineer will provide advanced technical and engineering support to a new automated packaging project. This engineer will use the required engineering competencies and systems training to support the automation project.
Responsibilities
* Responsible for managing and delivering key project tasks assigned
* Work with automation vendor, engineering, and other functions in delivering key project task assigned
* Actively interfacing with cross-functional team members and vendors, and always practicing good teamwork in support of the project requirements in pursuit of achieving project milestones
* Support the project team where required in delivering a world class automation project
* Review and support vendor documentation such FDS, SDS, electrical/pneumatic drawings, training material, commission reports etc and other documents as required
* Generate, review, and approve project validation documentation URS, PFMEA's FAT, SAT, VP, IQ, OQ, PQ, reports, procedures, and other documents as required compliant with current Good Manufacturing Practices (GMP)
* Provide technical guidance in the machine hardware/software design/functionality to the vendor and project team
* Attend and execute the automation system pre-FAT and FAT execution at vendor's site
* Execute validation qualification test protocols documents
* Support debugging the automated system with structured problem solving and providing feedback to the project team and vendor
* Support install of the automation system at the site in readiness for qualification
* Observing the Quality Management Systems requirements on site at all times
* Adherence to, and enforcement of all Environment Health and Safety (EHS) requirements on site.
Requirements
* Level 8 Degree in Mechanical Engineering
* Has 2-4 years' experience in a manufacturing environment
* Software knowledge would be beneficial
* Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment
* The individual should enjoy working in a fast paced, dynamic and results orientated project team environment
* Innovative thinker - able to envisage new and better ways of doing things
* Strong communication and influencing skills with internal and external agents
* Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment
* Demonstrable analytical & problem solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment
* Experience in an FDA regulated or regulated industry beneficial
* Excellent presentation and written / verbal communication skills
* Demonstrable ability to work autonomously
* A team player, with a flexible approach
* Technological pioneer, willing to source, investigate and implement technological and automation advances
* Confident and effective decision maker, with a proven leadership ability to negotiate and influence others.
Benefits
* Competitive and attractive employee compensation package
* Pension contributions
* Health insurance
* Paid public holidays
Location: Limerick, Ireland | onsite
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