
Validation / Process Development Engineer
16 hours ago
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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