Process Engineer (Chief Engineer's Department)

OCTAPHARMA-PHARMIMEX LLC is a Swiss-Russian enterprise consisting of two legal entities: Octapharma AG and JSC Pharmimex. The company was created with the goal of constructing a pharmaceutical plant in the Skopin district of the Ryazan region and launching a full cycle of production for medicinal products based on human blood plasma. The localized products have been present in the Russian market since 1995 and are produced to support the life and health of patients in three therapeutic areas: hematology, immunotherapy, and intensive care. We are looking for a Process Engineer who will become part of the Chief Engineer's Department team of the technical service and will be responsible for the implementation of the company's production processes. Please note that this position involves relocation to the Ryazan region, Skopin district, s. Uspenskoye.

Responsibilities:

• Participation in the review of developing design documentation for the production site; ensuring the implementation of engineering solutions in the project that comply with current international and local standards, environmental protection requirements, and safety regulations.
• Review of design documentation: process diagrams, piping and instrumentation diagrams, URS, drawings, functional specifications, component specifications, etc.
• Participation in the execution of design and qualification activities: design, equipment manufacturing and Factory Acceptance Test (FAT), installation, commissioning, acceptance, and qualification - DQ/IQ/OQ/PQ.
• Participation in the implementation of corporate standards for new equipment and maintaining them throughout the equipment lifecycle.
• Participation in the development of procedures and instructions for equipment operation and maintenance, and other necessary documentation.
• Responsibility for keeping documentation up to date.
• Troubleshooting and timely resolution of technical problems to support the launch and operation of the facility in a steady state.
• The scope of support will include: fractionation and purification lines, including process equipment (reactors, vessels, filtration and chromatography units, valves, pumps, CIP/SIP cleaning systems, washing machines, autoclaves, water baths).
• Participation in maintaining systems in a qualified/commissioned state, training system users and personnel.

Requirements

Higher engineering education: pharmaceutical, chemical, biotechnological. Knowledge of pharmaceutical production standards, process and quality standards, safety, and hygiene. Experience in similar functions at a pharmaceutical enterprise of at least 2 years is mandatory. Experience working in a pharmaceutical production environment with process equipment (reactors, vessels) is mandatory. Experience in conducting process equipment acceptance (FAT), installation and commissioning works, participation in qualification activities (IQ/OQ), maintenance, diagnostics, and troubleshooting (mechanical and/or in the automation system). Knowledge of the operating principles and technical characteristics of various types of process equipment (liquid processes, batch production). Ability to work with measuring instruments and tools. Skills in reading and understanding technical documentation, diagrams, and drawings. Knowledge of AutoCAD, MS Office. Proficiency in technical English (reading documentation, conducting correspondence). Knowledge of EU and RUS-GMP.

Higher education — Bachelor's degree; Experience: 3 years