5 Aseptic Filling Jobs

As an R&D Executive at VTC R&D, you are responsible for performing and overseeing all activities related to formulation and filling process development. Your duties include having a strong understanding of optimizing vaccine formulations, selecting stabilizers and excipients, as well as preparing adjuvants such as aluminium salts, Oil-In-Water emulsions, Liposome-based adjuvants with TLR agonists and saponin, and LNP formulation. You will also be involved in aseptic filling and Lyophilization cycle designing for new vaccine products and troubleshooting existing vaccines. In this role, you will execute clinical drug product manufacturing for clinical batches, plan and carry out media fill activities, and maintain R&D lab documents, equipment, and area qualifications in compliance with GMP requirements. Additionally, you will be responsible for preparing process validation and technology transfer protocols as per GMP requirements and collaborating with QA, QC, and Engineering departments for viral vaccine development activities. Ensuring proper hygiene and entry exit procedures in the formulation and filling section, preparing adjuvants, buffer solutions, and other materials, as well as coordinating with the central warehouse department for materials receipt and entry are also part of your responsibilities. You will supervise the preparation of disinfectant solutions, cleaning solutions, integrity testing of filters, and sanitization and disinfection activities in the R&D formulation department. As part of the QMS, you will handle deviations, MDD, investigations, observations, and ensure their timely closure. You will be involved in preparing standard operating procedures, batch manufacturing records, QRM, and protocols related to the R&D formulation and filling section. Moreover, you will supervise the washing, drying, packing, and sterilization of materials required for R&D development and GMP clinical batch preparation. Your role as an R&D Executive will be crucial in advancing vaccine development and ensuring compliance with quality standards and procedures.,

You will be responsible for performing and documenting all activities related to the formulation and filling process development. Your role will involve optimizing different vaccine formulations, selecting stabilizers and excipients, as well as preparing adjuvants such as aluminium salts, Oil-In-Water emulsions, Liposome-based adjuvants with TLR agonists and saponin, LNP formulation, aseptic filling, and Lyophilization cycle designing for new vaccine products. Additionally, you will troubleshoot existing vaccines as needed. You will execute the clinical drug product manufacturing for clinical batches, plan and carry out media fill activities, and maintain R&D lab documents, equipment, and area qualifications in compliance with GMP requirements. Furthermore, you will be responsible for preparing process validation and technology transfer protocols as per GMP requirements and collaborate with QA, QC, and Engineering departments for viral vaccine development activities. Ensuring proper hygiene and entry/exit procedures in the formulation and filling section will be part of your responsibilities. You will also prepare adjuvants, buffer solutions, and other materials, and coordinate with the central warehouse department for the receipt and entry of raw materials and packaging materials. Supervision of disinfectant solutions, cleaning solutions, integrity testing of filters, and sanitization activities in the R&D formulation department will also be under your purview. Managing QMS processes such as deviations, MDD, investigations, observations, and ensuring timely closure will be crucial. You will also be involved in preparing standard operating procedures, batch manufacturing records, QRM, and protocols related to the R&D formulation and filling section. In addition, you will oversee the washing, drying, packing, and sterilization of materials required for R&D development and GMP clinical batch preparation. Preferred Candidate Profile: - Ph.D./M.Sc. in science (Biotechnology, Biochemistry, and Microbiology) or Masters Degree in Pharmacy or Engineering with biotechnology. - Experience in the vaccine industry. - Ability to work at the bench level, and this position involves one reporting relationship.,

Witnessing of manufacturing processes for sterile drug products including cleaning, sanitization, environmental monitoring and personnel monitoring to ensure compliance with CGMP regulations and regulatory standards Oversight of cleanroom behavior, contamination control and aseptic techniques To report any observations to site operations and quality and ensure compliance to the observations Review of media fill protocol and reports and witnessing aseptic process simulations Review of batch documentation to ensure product quality, regulatory compliance and meeting ALCOA++ requirements Review of environmental monitoring reports Review of unplanned deviations and CAPA

As an experienced PLC Engineer with a minimum of five years of desirable experience, you will be responsible for installation, commissioning, troubleshooting, optimization, and validation of aseptic filling and packaging equipment in Food / Beverage plants. Your expertise in Siemens S7 programmable logic controllers, HMI configuration, process validation, and Logic Simulation will be crucial for the successful execution of projects. Furthermore, experience in other PLC systems like Rockwell Automation would be advantageous. Your role will also require a good understanding of different process sensors, instruments, measurements, and servo drives of aseptic filling and packaging equipment, along with proficiency in interfacing with PLC systems. Knowledge of PLC interfacing with other systems such as OPC UA and Modbus, as well as experience in Power / Water projects involving PLC-DCS-SCADA, will be beneficial. You should have a strong grasp of P&ID drawings and the ability to create and modify process graphics. Additionally, you will be expected to possess good knowledge of using test instruments for start-up and commissioning activities, as well as experience in FAT-SAT of PLC-based control systems, loop checking, and documentation of software and hardware. The role will also involve leading a team of technicians for wiring and instrument troubleshooting, necessitating strong team leadership skills. Being a good team player and having experience in working and coordinating with cross-functional engineers will be essential in this role. Your success in this position will be driven by your adherence to strong professional and personal values.,

Role & responsibilities Supervise day -to-day operations of the manufacturing and packaging lines to meet production target. Monitor all stages of the line process, including filling, sealing, labeling, and final packaging. Ensure quality checks are performed on the line, including visual inspection , fill levels, seal integrity , and label accuracy. Identify and isolate defective production and immediately report deviations to the quality team. Collaborate with QA/QC maintenance, and warehouse teams to ensure smooth operations. Ensure machines are cleaned and setup correctly during batch changeovers. Ensure all work is performed with a strong focus on safety, hygiene, and quality. Preferred candidate profile -5 years of experience in pharmaceutical manufacturing, preferably in aseptic filling or line supervision role. Strong understanding of GMP regulations and industry standards (e.g., FDA). Excellent supervisory skills, with ability to motivate team members towards achieving goals. Proficiency in MS Office applications (Word, Excel) for documentation purposes. Regards Somi ghosh 783804667 HR- Manager