About ProSys
ProSys, established in 1997 and headquartered in Cork, Ireland, specialises in the design and manufacture of specialist capital equipment for the pharmaceutical industry.
Our products include both standard & custom engineered containment and aseptic solutions. Our philosophy is to contain any hazard at the source, minimize cleaning, maximize flexibility, and maintain an environment that is safe for the personnel and the process. Due to continued growth we now have a vacancy for a Quality & Validation Engineer:-
RESPONSIBILITIES:
* Preparation of validation documents (e.g.FAT/SAT/IQ&OQ protocols)
* Project team member in delivering projects and involved in customer design meetings/URS reviews
* Design Qualification (Traceability Matrix) of projects
* Testing and troubleshooting equipment
* Cycle development of aseptic isolators & cycle validation of aseptic isolators at client sites
* Execution of SAT protocols at client sites
* Review of machine certification, production build data and inspection of equipment
* Work with project and production teams on non-conforming reports and change controls
* Draft and revise testing SOPs and quality documentation
ROLE REQUIREMENTS:
* Quality focused with knowledge and understanding of scientific rationale and cGMP quality systems
* Proven problem solving skills
* Team player
* Excellent interpersonal skills and the ability to communicate well, both verbally and written
* Excellent organizational and detail-oriented skills
* International travel – 30-40%
EDUCATION:
* Technical/Science or Engineering qualification to degree level or with equivalent experience
Job Types: Full-time, Permanent
Work authorisation:
* Ireland (required)
Willingness to travel:
* 25% (required)
Work Location: In person