ResponsibilitiesCoordinate laboratory equipment activity to satisfy demandsCommission equipment and prepare and execute IQ, OQ and PQ activities as requiredDevelop and implement best practices for laboratory activitiesCreate and maintain Standard Operating Procedures, maintenance procedures, and Health and Safety proceduresPerform all necessary laboratory and Product Development testing and supply data required for FDA submissionsConduct metallographic, optical microscopy, chemical and physical analysis, dimensional measurement, First Article Inspection, etc., on metals, polymers, and other materials as requiredConduct DOEs, capability studies, MSAs, write technical reports, provide technical support, address workmanship standards, resolve product quality issues, support quality control, and facilitate engineering support such as ECN generationSupport 3D‑Printing prototyping: prepare CAD files, convert to STL, prepare and operate the 3‑D printer, perform post‑processing and inspectionWork closely with the Quality Department to ensure documentation associated with validation and new product introduction in a regulated environment is accurate, executed in the correct sequence, and completed promptlyParticipate in PFMEA, Control Plan, SOP, and PPAP generation for product transfers and launchesProvide training for manufacturing team membersEnsure adherence to GMP and safety proceduresPerform all other duties as assignedQualificationsDiploma/trade in a related disciplineMinimum of 2 years of experience as a technician or in a technical roleKnowledge of metallographic preparationKnowledge of ASTM and ISO specificationsStrong computer literacyExperience with validation activities in a regulated industryDemonstrated mechanical/technical aptitudeStrong communication skillsAbility to work independently and as part of a team in a fast‑paced, results‑oriented environmentProven problem‑solving skills and a hands‑on approachExperience working in a regulated GMP‑based machine‑floor environmentCapable of working as part of a multi‑disciplined teamAbility to meet timelines and adhere to deadlinesAttention to detail and accuracy when completing documentationWork Flexibility23‑month fixed‑term contract. The role allows up to 10% travel. Working arrangements can be 100% remote, onsite, or hybrid depending on the assignment location.
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