Job Description
Our client are seeking an experienced engineer who can provide advanced technical and engineering support for upcoming projects in their manufacturing division. This engineer will use the required engineering competencies to support their team.
Responsibilities
* Responsible for managing and delivering key project tasks assigned
* Work with automation vendors, 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
* 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
* Experience in an FDA regulated or regulated industry beneficial
* Validation ownership experience for equipment and processes