JLE Consulting provides consulting and engineering services to the pharmaceutical and biotechnological industries. The company's core activities include project management, engineering, process optimization, GMP audit preparation, and strategic planning for the production of medicinal products and biotechnological products.
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Industry:Technical Consulting & Engineering
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Strategic planning, process optimization and GMP audit preparation for pharmaceutical manufacturing processes; support with cost analysis, workflow simulation and project planning.
Engineering
Planning and basic design across the entire project life cycle; feasibility studies, business case development, concept evaluation and technical execution for pharmaceutical and biotech facilities.
Project Management and Coordination
Management of all project disciplines, scheduling and control of dates, cost monitoring, risk analyses and procurement strategy up to successful handover.
Document Management
Introduction and management of document management systems, secure document flows, upload and distribution control, archiving and status tracking throughout the project duration.
Process and Design Engineering
GMP-compliant equipment and room design, optimization of personnel and material flows, concept evaluation, process simulations, and development of PFDs and P&IDs.
Architecture
Greenfield and brownfield planning, review of site master plans, architectural documentation, structural calculations, space and building planning, and cleanroom engineering.
Media and infrastructure planning
Planning and coordination of HVAC, plumbing, clean utilities, electrical systems and automation; room pressure, piping routing, and building management systems for water, steam and air.
Qualification and Commissioning
GMP risk analyses, cGMP design reviews, support for FAT/SAT, CQV documentation and execution of DQ, IQ and OQ.
HSE consulting
Integration of Health, Safety and Environment principles, safety stops, and assessments of design, personal safety and environmental protection across all project phases.
Pharmaceutical planning and support
Support for the planning and development of pharmaceutical facilities, including fill & finish, OSD production, packaging, logistics and warehousing solutions, as well as medical devices and diagnostics.
Biotech planning and support
Planning of biotech processes for pharmaceutical production, including upstream and downstream processing, fermentation scale-up, monoclonal antibodies and viral vectors.
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