משרות תוצאות חיפוש מתאימות לבקשתך:

The opportunity
As the Lab Equipment Specialist you will primarily focus on ensuring the efficient and compliant operation of sophisticated laboratory equipment used for analytical testing in the production of Cytotoxic drug products. This involves assessing, qualifying, validating, and implementing high-end laboratory equipment, managing related documentation, and ensuring adherence to regulatory standards. The role also focuses on continuous improvement, maintaining quality systems, coordinating with multiple departments and contractors, and acting as a key liaison between suppliers and the laboratory.
How you’ll spend your day
Assess, qualify (including validation), and implement sophisticated high-end (computerized) laboratory equipment.
Determine priorities within your project while tracking project execution across multiple departments.
Oversee the timely completion of all validation documentation, including coordinating contractor activities.
Support the regulatory defense of validation protocols and summary reports during audits and internal audits.
Review quality system documents, including CAPA, change controls, investigations, and deviations.
Develop and support continuous improvement initiatives for the validation of equipment, facilities, utilities, and control systems.
Present project status to stakeholders and (senior) management.
Write training instructions, calibration, maintenance, operational procedures, equipment specification files, and reports (URS, Risk assessments, IQ/OQ/PQ).
Act as a Subject Matter Expert and actively participate during audits.
Serve as the point of contact between suppliers and the laboratory.
Manage contracts for maintenance and/or calibration.
Manage computerized systems and applicable software.
Develop Validation Master Plans, Validation Project Plans, and Project Schedules as needed.