Equipment Lifecycle Engineer
Core
Ensuring equipment is qualified throughout its lifecycle to meet regulatory guidelines and client requirements for GxP systems.
Role type
Equipment Lifecycle Engineer
Builds
Qualified laboratory equipment and systems for pharmaceutical testing
Domain
Life Sciences / Pharmaceutical Testing / GxP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Preventive and corrective maintenance, calibration, validation/qualification, data integrity assessment, supplier selection, URS drafting, non-conformance management, workflow creation
Preferred skills
Laboratory experience, general IT systems proficiency
Technologies
MS Office
Responsibilities
Performing preventive and corrective maintenance on laboratory equipment; Performing calibration work on utilities and laboratory equipment; Performing validation/qualification of laboratory equipment; Performing periodic evaluations and assessments on data integrity; Identifying, reporting and handling malfunctions of utilities, laboratory equipment and facilities; Training and advising colleagues in the use, maintenance, calibration and validation of utilities and laboratory equipment; Managing new equipment (supplier selection, drafting URS) and providing related documentation; Initiating and solving non-conformances, out-of-specifications, changes and complaints in collaboration with the QA team; Creating good system workflows in collaboration with operations departments
Seniority
Entry-level to Mid-level, hands-on IC