Packaging and Validation Engineer
3 weeks ago
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
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