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Quality & validation engineer

Carrigtwohill
Prosys Sampling Systems Ltd
Validation engineer
Posted: 26 February
Offer description

About ProSysProSys, 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 reviewsDesign Qualification (Traceability Matrix) of projectsTesting and troubleshooting equipmentCycle development of aseptic isolators & cycle validation of aseptic isolators at client sitesExecution of SAT protocols at client sitesReview of machine certification, production build data and inspection of equipmentWork with project and production teams on non-conforming reports and change controlsDraft and revise testing SOPs and quality documentationROLE REQUIREMENTS:Quality focused with knowledge and understanding of scientific rationale and cGMP quality systemsProven problem solving skillsTeam playerExcellent interpersonal skills and the ability to communicate well, both verbally and writtenExcellent organizational and detail-oriented skillsInternational travel – 30-40%EDUCATION:Technical/Science or Engineering qualification to degree level or with equivalent experienceJob Types: Full-time, PermanentWork authorisation:Ireland (required)Willingness to travel:25% (required)Work Location: In person

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