Expert Engineering/Inženir ekspert
Core
Technical owner for manufacturing equipment and systems throughout their lifecycle in a clinical biopharmaceutical environment, ensuring GMP compliance and operational reliability.
Role type
Senior IC manufacturing engineering expert (biopharma)
Builds
Reliable clinical manufacturing assets for drug substance and drug product development
Domain
Biopharmaceuticals / Clinical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical/Electrical/Mechatronics engineering, GMP compliance, equipment lifecycle management, troubleshooting, root cause analysis, capital project execution, regulatory inspection support
Preferred skills
Pharmaceutical/biotech industry experience, automation systems knowledge, mentorship
Technologies
Bioreactors, chromatography systems, TFF, centrifuges, isolators, aseptic processing lines, clean utilities (WFI, steam)
Responsibilities
Manage equipment lifecycle activities including maintenance strategies and spare parts management; Participate in capital investment projects and technical transfers including FAT/SAT and IQ/OQ/PQ; Troubleshoot complex equipment and process-related issues to minimize downtime; Support regulatory inspections and internal quality assessments; Mentor engineers and technicians across multidisciplinary activities
Seniority
Senior, hands-on IC
