Expert Engineering/Inženir ekspert
$27,510–$51,090 year
On-siteMengeš, Mengeš, Slovenia
Job Summary
Act as technical owner for Drug Substance, Drug Product, and supporting utility equipment throughout the entire asset lifecycle. Manage equipment lifecycle activities including maintenance strategies, reliability improvements, spare parts management, obsolescence management, and asset replacement planning. Participate in capital investment projects and technical transfers, including URS development, design reviews, FAT/SAT execution, commissioning, IQ/OQ/PQ, and system handover to operations. Support change controls, investigations, deviations, CAPAs, and periodic reviews associated with equipment and systems. Troubleshoot complex equipment and process-related issues to minimize downtime and maximize operational performance. Collaborate with suppliers and service providers to ensure long-term equipment sustainability and technical support. Support regulatory inspections and internal quality assessments. Contribute to continuous improvement initiatives focused on reliability, operational excellence, and process efficiency. Mentor and technically support engineers and technicians across multidisciplinary engineering activities.
Required Qualifications
- University degree in Mechanical Engineering, Electrical Engineering, Mechatronics, or a related discipline
- 3+ years of engineering experience
- Practical experience with commissioning, qualification, maintenance and lifecycle management of manufacturing equipment
- Strong troubleshooting and root cause investigation skills across mechanical, electrical and automated systems
- Experience working within GMP-regulated environments
- Ability to work independently while effectively collaborating across multidisciplinary teams
- Excellent communication skills
- Proactive problem-solving mindset
Desired Qualifications
- Experience within pharmaceutical, biotechnology, life sciences or other regulated industries
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