Head of Fractionation
Более 3 лет
As an international family business in the plasma industry, we are proud of this: our products can save lives. We have strong European roots and are growing continuously. Therefore, we are looking for a Head of Fractionation, who will be responsible as part of the team for a global construction project in Russia. Please pay attention that the Candidate will have frequent business trips (up to 70%) to Skopin (Ryazan region) and Europe first working year (depends on project schedule) and later in 2024 will relocate to Skopin, Ryazan region to oversee the implementation of the project there and help in operation of the facility. Head of Fractionation will be responsible for: Review and study of project documentation (mass balances, process diagrams, pipeline and instrument diagrams, URS, drawings, diagrams, flows of materials and personnel, functional specifications, component specifications, etc.). Participation in the development of project documentation for the fractionation production site; ensuring the implementation of the best engineering solutions in the project, corresponding to all current international and local standards, environmental, occupational health and safety requirements. Budget responsibility for Department, including manpower, production capacity, capex, and process yields. Organization of all commissioning, qualification and validation (CQV) activities related to this area and commissioning of the facility. Management of development, planning, implementation and maintenance of production methods of fractionation processing, ensuring compliance with GMP requirements. Participation in the development of modeling of production processes. Maintenance of production lines in qualified/commissioned condition, training of users and control of all necessary maintenance and repair work at the stage of operation of these lines. Troubleshooting and timely resolution of technical problems in support of the launch and operation of the facility in steady-state mode. Reduction of production events (any deviations from processes) and user interventions. Development of solutions to reduce production cycle time, ensure error-free operations and eliminate losses. Development of procedures and instructions for the operation and maintenance of the entrusted equipment Maintaining GMP compliance of department documentation, such as but not limited to: - writing, reviewing, approving department SOPs; - reviewing and department release of executed batch records; - supporting root cause investigations as part of deviation management; - supporting Change control management. What do we expect? Knowledgeable of pharmaceutical manufacturing and related equipment, and capable of performing all CQV work related to the startup of a fractionation facility. Higher education in sciences - preferably in the area of Chemistry, Biology, Pharmacology, Biochemistry, Pharmaceutical Technology, or Process Engineering. GMP and pharmaceutical production experience for at least 5 years. Prior working experience as manager in production as a plus. Fluent in English – B1 and higher. Strong working knowledge of Microsoft Office. Excellent management skills and leadership (incl. leading by example and employee motivation). Excellent communication skills, analytical thinking Responsibility, honesty, flexibility, openness, ability to work with a large amount of information. Excellent organizational skills including attention to detail and multitasking skills. What we offer? Reliable employer with generous social benefits: Competitive salary; Accommodation in Company’s modern Housing Complex in Skopin; Annual bonus; Medical and life insurance; Daily meal allowance; Fitness compensation; Mobile phone compensation; International training programs; International environment, friendly and highly-motivated team; Interesting and challenging tasks; Career advancement possibilities.