Job Description
As a senior packaging and validation engineer, you will provide advanced technical support to an automated packaging project. This role requires the use of engineering competencies and systems training to deliver key project tasks assigned.
Responsibilities:
* Manage and deliver key project tasks assigned to ensure timely completion.
* Collaborate with automation vendors, engineers, and other functions to deliver key project tasks assigned.
* Interface with cross-functional team members and vendors, practicing good teamwork to achieve project milestones.
* Support the project team in delivering a world-class automation project.
* Review and support vendor documentation such as FDS, SDS, electrical/pneumatic drawings, training material, commission reports, and other documents as required.
* Generate, review, and approve project validation documentation including URS, PFMEA's FAT, SAT, VP, IQ, OQ, PQ, reports, procedures, and other documents compliant with current Good Manufacturing Practices (GMP).
* Provide technical guidance on machine hardware/software design/functionality to vendors and project teams.
* Attend and execute automation system pre-FAT and FAT execution at vendor sites.
* Execute validation qualification test protocols documents.
* Support debugging the automated system with structured problem-solving and providing feedback to project teams and vendors.
* Install automation systems at sites in readiness for qualification.
* Adhere to Quality Management Systems requirements on site at all times.
Required Skills and Qualifications:
* Level 8 degree in Mechanical Engineering.
* 2-4 years' experience in a manufacturing environment.
* Software knowledge beneficial.
* Self-starter with efficient work methods, analytical & problem-solving skills, and ability to handle multiple tasks in a fast-paced environment.
* Ability to work in a fast-paced, dynamic, and results-oriented project team environment.
* Innovative thinker able to envision 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, process improvement orientation, and 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 proven leadership ability to negotiate and influence others.
Benefits:
* Competitive employee compensation package.
* Pension contributions.
* Health insurance.
* Paid public holidays.
Location: Limerick, Ireland