Summary The "SVP (Small Volume Parenteral) Biologics Operator I is responsible for the production of highly expensive and sensitive Biological Parenteral product, and is trained to carry out its tasks in different areas of the process, such as cleaning and preparing equipment, formulating solutions" process testing, filtering and transfer of solutions, and will also be trained to provide support in the aseptic filling of small volume syringes with the use of "RABS" (Restricted Access Barrier System) and inspection of the filled product in its final package. in daily production operations, operating different equipment such as parts washers, autoclaves, CIP (Cleaning in Place) systems, SIP systems (Sterilization in Place), formulation tanks, filter integrity testing machine, magnetic stirrers. Make inventory of materials and parts necessary for manufacturing, perform process tests as required It will monitor alarm systems. Assemble equipment and perform cleaning and sterilization procedures. Comply with Good Manufacturing Practices (GPS) and with standard procedures (SOP's). Inform the supervisor about any event that occurred during the work shift. Main responsibilities The incumbent is responsible for complying with the company's policies with the procedures of the ABL plant and with the regulations and requirements of Good Manufacturing Practices (GMP) of the Federal Food and Drug Administration (FDA). Work on the cleaning, preparation and sterilization of manufacturing equipment. Work aseptically in the formulation of biological parenteral product. Perform process samples such as pH, density, and osmolality. Inspect the equipment to verify that they are operating within the established parameters. Carry out cleaning operations, pressure testing, sterilization of equipment, integrity of filters and "RABS" gloves, filtration of solutions, aseptic filling, product inspection. Monitor processes through computerized systems and visual inspection of equipment and recognize when process parameters are diverted to alert and take action to avoid process deviations and / or product loss. Receive and verify materials for the manufacture of the final product. Participate and assist in the qualification and validation activities of the "SVP" area. Keep a detailed record of the operations carried out during the work shift, "batch records", "log books" and perform the required inventory transactions, either manually or electronically. Handle and dispose hazardous and non-hazardous materials according to established procedures. Attend and complete the internally trained training on industrial hygiene, occupational safety and good manufacturing practices (GMP, SARA, CHAP, BOP and others). Use the required personal protective equipment (PPE) and notify the supervisor of incidents or unsafe conditions in the work area. Responsible for operating efficiently in order to obtain the best product performance. Carry out production documentation in a legible manner, without errors and on time, following good documentation practices and good manufacturing practices. Audit the "batch records" and "log books" of production as required. Maintain clean facilities following procedures, so aseptic conditions are maintained. Diagnose and resolve events or exceptions of highly complex equipment and processes through the interface of systems such as (HMI) "Human Machine Interface" (PLC) "Process Logics Controls". Have an understanding and basic knowledge of equipment and processes with automated systems. Attend other areas within SVP as required or necessary. Provide assistance to operations in the control, management and disposal of domestic, biomedical and hazardous waste from their respective area as applicable, ensuring compliance with Federal local regulations following the procedures and policies of the plant. Educational Requirements Associate Degree in Natural Sciences, preferably in Chemistry, Biology, Microbiology or related areas. You can have an associate degree in instrumentation, automation, electronics or mechanics with experience in the area of biotechnological processes or an associate degree in business administration. Basic knowledge of laboratory techniques. Basic knowledge of computer systems. Desirable DeltaV, SAP, MES. Ability to read, write, interpret and communicate instructions in English and Spanish. Mathematical skills Knowledge and experience in techniques for formulating solutions, cleaning and sterilizing equipment. At least two years of experience in the manufacturing area in the chemical, pharmaceutical or biological processes industry. Preferable two years of experience as a biological operator in the biotechnology plant. Mental and Physical Capabilities Mental Skills Required (Example.: Ability to work with multiple priorities in a frequent interruption environment) Ability to work with compressed itineraries managing multiple priorities with minimum supervision. Ability to lead groups and achieve the effective realization of tasks and resources. Excellent interpersonal relationship skills. Basic skills for identification and analysis of chemical problems and processes and biological manufacturing. Ability to read and understand technical information, procedures, and other documents in English. Heavy equipment transportation. Knowledge of Good Manufacturing Practices (GMP's) and safety standards. Basic skills for identification and analysis of problems and chemical and biological manufacturing processes. Skill in the operation of computers (MES, SAP) and automated systems (Delta V). Verbal and written communication in English and Spanish. Available to work first and second shift, extended shifts and weekends, as required. Available to work additional time when required. Good interpersonal relationship skills. Knowledge of quality regulations and standards that affect chemical, biological or medical devices (i.e. Quality Systems, FDA Regulations, and EN46000). Knowledge of safety regulations and OSHA for corporations, local area and state. Basic knowledge of laboratory techniques. Basic knowledge of computer systems. Desirable DeltaV, SAP, MES. Ability to read, write, interpret and communicate instructions in English and Spanish. Mathematical skills. Basic mechanical skills. SDL2017
Ciudad: barceloneta
