Sr Project Engineer

Responsibilities

• Innovation & development of new/alternative processing technologies for the development of new complex formulations or for the improvement of current commercial products for parenteral nutrition and generic pharmaceuticals.
• Evaluates state-of-the-art concepts and methods for scaling-up of pharmaceutical formulations manufacturing technologies developed at lab & pilot plant scales.
• Project leader regarding engineering design (formulation and/or processing) of complex fluid-based products, such as lipid emulsions, lyophilized products, total parenteral nutrition (TPN) in the pharmaceutical and nutritional fields.
• Project leader, including planning, experimental work by means of state-of-the-art techniques, data evaluation, documentation, and project reporting regarding new/alternative pharmaceutical formulations manufacturing technologies, such as: High-pressure homogenization, Microfluidization, Lyophilization (Freeze-drying), Spray-freeze-drying, Steam sterilization, Ultra-High Temperature (UHT) sterilization.
• Project leader, including formulating URSs and following up their procurement, commissioning (FDS, SDS, HDS, DQ), qualification (IQ, OQ), and installation of equipment and processes, such as high-pressure homogenization, microfluidization, lyophilization (Freeze-drying), spray-freeze-drying, steam sterilization, and ultra-high temperature (UHT) sterilization.
• Captains and leads a project team responsible for the performance and supervision of technology transfer of complex formulations and processing technologies to manufacturing scale, including scientific and technical support.
• Provides leadership to ensure timely and within budget completion of assigned projects.
• Provides technical expertise for the development of conceptual design and P&IDs for GMP-based manufacturing of pharmaceutical products.
• Ensures technical and quality compliance of pharmaceutical manufacturing processes.
• Analyzes production and processing problems in pharmaceutical complex formulations and initiate project definitions to resolve them.
• Analyzes feasibility of the conceptual projects and prepares detailed analysis, including time and cost for completing the projects.
• Supports lab to production scale-up activities in collaboration with multidisciplinary and international teams.
• Designs and hands on execution of engineering studies to support new equipment start-up and process improvements.
• Develops process specifications for formulation of lyophilization and conventional small molecule injectable as well as emulsion and complex formulation, including equipment skids, product delivery systems, pressure vessels, pumps, compressors, heat exchangers and all associated equipment.
• Calculates and organizes data for process flow diagrams including instrumentation and control considerations.
• Prepares specifications and process instructions to operate equipment.
• Develops and maintains Process Instructions for manufacturing equipment in accordance with site Change Control and Validation requirements.
• Identifies and implements process improvements.
• Identifies and specifies process-specific equipment.
• Troubleshoots, amends and accommodates the process of aseptic formulation and fill of drug product.

Qualifications

• BS in chemical, process or pharmaceutical engineering or related field; advanced degree strongly preferred.
• 5 years of professional experience working in pharmaceutical industries focusing on pharmaceutical complex formulations (e.g. lipid emulsions and lyophilization formulations) and manufacturing technologies (e.g. high-pressure homogenizers, microfluidizers, freeze-driers, and sterilization techniques).
• 5 years hands on experience with validated manufacturing process systems.
• 5 years of batch or continuous process system design and implementation.
• Emulsion formulation and processing experience
• Lyophilization formulation design experience
• Freeze-drying process design, optimization, and scale-up
• Ability to design experiments and analyze resulting data
• Process Control and Instrumentation experience
• Working knowledge of process engineering processing aids such as sanitary connections, valves and pharmaceutical process design
• Working knowledge of AutoCad or SolidWorks
• Knowledge of Clean Room Classifications and process preferred
• Project Management experience in a food, pharmaceutical or regulated environment preferred
• Experience with critical utilities (WFI, OFCA, Clean Steam, HVAC)
• CIP/SIP experience is desired
• Experience with process equipment designed for Cytotoxic/Potent API containing products is desired
• Six Sigma Training a plus
• Excellent verbal and written communications skills